Uterine Cervical NeoplasmsPhase 2QUARTZ-CCNCT07646301
Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706), Paclitaxel and Cisplatin in people with Uterine Cervical Neoplasms and Locally Advanced, run by Sun Yat-sen University at 1 site in China.
Trial summary
Purpose: To evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP/TC regimen) for patients with locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Locally Advanced
- What is being tested?
- Iparomlimab and Tuvonralimab (QL1706), Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years.
- Histologically or cytologically confirmed cervical cancer, FIGO stage IB3 or IIA2.
- Imaging findings showing pelvic lymph node short-axis diameter < 1.5 cm and para-aortic lymph node short-axis diameter < 1.5 cm.
- Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- No prior anti-tumor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Who cannot join
- Presence of other concurrent malignancies.
- Pregnant or peripartum women.
- History of myocardial infarction or stroke, unstable angina, decompensated heart failure, or deep vein thrombosis.
- Presence of NCI-CTCAE version 5.0 grade ≥2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Active unresolved hepatitis, defined as progressive decrease in appetite, general weakness, nausea, acid reflux, aversion to oily foods, abdominal distension, or abnormal liver function with jaundice (e.g., scleral or urinary jaundice); for hepatitis B, HBV DNA > 1000 IU/mL.
- Hepatic insufficiency (aspartate aminotransferase/alanine aminotransferase > 2.5 × upper limit of normal).
Show all 16Show fewer
- Renal insufficiency (serum creatinine > 2 × upper limit of normal).
- History of chronic pulmonary disease with restrictive respiratory dysfunction.
- History of major organ transplantation or autoimmune disease.
- History of severe mental illness or cerebral dysfunction.
- History of substance abuse or drug addiction.
- Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (dose > 10 mg prednisone or equivalent) within 2 weeks prior to enrollment, with ongoing use.
- Coagulation abnormality (INR > 2.0, PT > 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy (prophylactic low-dose aspirin and low-molecular-weight heparin are permitted).
- Congenital or acquired immunodeficiency (e.g., HIV infection).
- Receipt of inactivated vaccine within 30 days prior to the first dose of study treatment.
- Inability or unwillingness to provide written informed consent or comply with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Chun-Yan Chen, +86 20 87341779, chenchuny@sysucc.org.cn
Jihong Liu, Ph.D.
About this study
Official title: Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Prospective Single-Arm Phase II Trial
Purpose:
To evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP/TC regimen) for patients with locally advanced cervical cancer.
Read more
Eligibility Criteria:
Women aged 18 to 70 years with newly diagnosed, histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO stage IB3 or IIA2, with no evidence of significant lymph node involvement (pelvic and paraaortic lymph nodes <1.5 cm in short diameter), and who have not received any prior anticancer therapy.
Study Procedures:
Participants will receive up to 4 cycles of QL1706 plus TP/TC chemotherapy (once every 3 weeks) prior to surgery. After 2 cycles, clinical assessment will be performed to evaluate tumor response. If tumor shrinkage is observed, treatment may continue for 2 additional cycles, followed by imaging evaluation. Depending on the response, participants with complete or partial response may undergo less extensive surgery (cervical conization plus sentinel lymph node biopsy) rather than standard radical hysterectomy. After surgery, participants who achieve a major pathological response will receive QL1706 maintenance therapy as a single agent for up to 8 additional cycles (once every 3 weeks). For participants with insufficient tumor response, standard radical hysterectomy will be performed. Postoperative adjuvant therapy (radiation or chemotherapy) will follow standard clinical guidelines.
Primary and Secondary Objectives:
The primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life.
Study Duration:
Total participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).
Read the detailed description
Detailed Description Background Cervical cancer remains the fourth most common malignancy among women worldwide. In 2022, approximately 660,000 new cases and 350,000 deaths were reported globally, with the heaviest burden observed in developing regions, particularly Asia, which accounts for nearly 60% of global cases and deaths. China alone contributes 22.8% of global incidence and 16% of global mortality.
Locally advanced cervical cancer (LACC, FIGO stages IB3 and IIA2) constitutes approximately 50% of all cervical cancer cases in China. Current standard of care is concurrent chemoradiotherapy (CCRT); however, 23.3%-34.4% of patients still experience disease recurrence or metastasis. Neoadjuvant chemotherapy (NACT) followed by radical surgery has been investigated as an alternative strategy, yet 9.8%-30.6% of patients fail to respond to NACT, potentially delaying effective local treatment. Moreover, over 30% of patients who undergo surgery require adjuvant radiotherapy, raising concerns regarding treatment burden and health economics.In recent years, immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy. Anti-PD-1/PD-L1 and anti-CTLA-4 antibodies exert complementary mechanisms of action. Emerging evidence supports the combination of neoadjuvant chemotherapy and immunotherapy for LACC. In the PACS study (presented at ASCO 2024), the pathological complete response (pCR) rate was 36.2%, and the optimal pathological response rate (residual tumor <3 mm) was 53.2%. Other studies, including NACI, MITO CERV3, and NATCI, have reported similarly encouraging pCR rates. Given the unmet medical need for more effective and less toxic neoadjuvant regimens, further evaluation of novel immunotherapy combinations such as the dual PD-1/CTLA-4 bispecific antibody iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy is warranted.
Detailed Treatment and Response-Adapted Algorithm Following neoadjuvant treatment (up to 4 cycles of paclitaxel plus cisplatin or carboplatin combined with QL1706), patients undergo clinical assessment after 2 cycles. If tumor shrinkage is observed, patients continue for 2 additional cycles followed by imaging evaluation. Based on imaging response: complete response leads to cervical conization plus sentinel lymph node biopsy or pelvic lymph node dissection; partial response leads to radical hysterectomy or trachelectomy plus sentinel lymph node biopsy or pelvic lymph node dissection. Patients achieving optimal pathological response (defined as pathological complete response or residual tumor depth ≤3 mm) receive 2 additional cycles of the same regimen followed by QL1706 maintenance therapy for 8 cycles. Non-optimal responders receive adjuvant therapy per NCCN guidelines. Patients who cannot tolerate surgery or have contraindications receive radical radiotherapy.
Sample Size Justification and Statistical Framework The sample size was calculated using Simon's two-stage optimal design (one-sided alpha=0.05, power=80%; null hypothesis pCR=30% vs. alternative pCR=43%). The first stage enrolls 33 patients; if 10 or more pCR events are observed, enrollment continues to a total of 94 evaluable patients. Accounting for 10% dropout, total target enrollment is 103 patients.
Data and Safety Monitoring An independent Data Monitoring Committee will oversee patient safety and conduct periodic reviews. The Committee may recommend early termination for efficacy, futility, or safety concerns. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, with written informed consent obtained from all participants.
- Conditions
- Uterine Cervical Neoplasms, Locally Advanced
- Being tested
- Iparomlimab and Tuvonralimab (QL1706), Paclitaxel, Cisplatin, Carboplatin
- Keywords
- Locally advanced cervical cancer, QL1706, Neoadjuvant chemoimmunotherapy, Pathological complete response, Phase II Single-arm Prospective study, QUARTZ-CC
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab (QL1706)Drug
250 mg administered intravenously over at least 30 minutes on Day 1 of each 21-day cycle for up to 4 cycles as neoadjuvant therapy, and up to 8 cycles as maintenance therapy (for patients achieving optimal pathological response).
PaclitaxelDrug
150-175 mg/m² administered intravenously over at least 3 hours on Day 1 of each 21-day cycle for up to 4 cycles, with standard premedication to prevent hypersensitivity.
CisplatinDrug
70-75 mg/m² administered intravenously over at least 1 hour, split over two consecutive days (Day 1 and Day 2) of each 21-day cycle for up to 4 cycles.
Cisplatin or Carboplatin according to investigator's choice
CarboplatinDrug
AUC=5 administered intravenously over at least 1 hour on Day 1 of each 21-day cycle for up to 4 cycles.
Cisplatin or Carboplatin according to investigator's choice
| Study group | Role | What they receive |
|---|---|---|
| QL1706 + TP/TC Neoadjuvant Chemoimmunotherapy | Experimental | Participants receive up to 4 cycles of neoadjuvant therapy (once every 3 weeks) with iparomlimab and tuvonralimab (QL1706 250 mg, IV) plus paclitaxel (150-175 mg/m², IV) and either cisplatin (70-75 mg/m², IV, split over 2 days) or carboplatin (AUC=5, IV). Treatment response is assessed after 2 cycles. For patients achieving tumor shrinkage, neoadjuvant therapy continues for 2 additional cycles followed by imaging. Patients achieving complete response (CR) undergo cervical conization plus sentinel lymph node biopsy (SLNB) or pelvic lymph node dissection (PLND). Those achieving partial response (PR) or non-optimal pathological response after surgery undergo radical hysterectomy/trachelectomy plus SLNB/PLND. Participants who achieve optimal pathological response (pCR or residual tumor depth ≤3 mm) after surgery receive QL1706 maintenance therapy for up to 8 cycles (once every 3 weeks). Patients who cannot tolerate surgery or have contraindications undergo radical radiotherapy. Receives: Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Proportion of patients with no residual invasive tumor cells in the surgically resected primary tumor specimen following neoadjuvant therapy.
Measured: At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days; patients receive 2 to 4 cycles)
Secondary outcomes (7)
Major Pathological Response (MPR) Rate
Proportion of patients with residual tumor depth ≤3 mm in the surgically resected primary tumor specimen following neoadjuvant therapy.
Measured: At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria on imaging after neoadjuvant therapy.
Measured: After 4 cycles of neoadjuvant treatment (each cycle is 21 days)
3-Year Overall Survival (OS) Rate
Overall survival rate at 3 years from study enrollment.
Measured: From date of first dose to date of death from any cause, assessed up to 36 months
3-Year Disease-Free Survival (DFS) Rate
Disease-free survival rate at 3 years from study enrollment.
Measured: From date of surgery to date of recurrence or death, assessed up to 36 months
Treatment-Related Adverse Events (TRAEs)
Incidence, grade, and relationship of adverse events (both conventional and immune-related TRAEs) assessed by NCI-CTCAE v5.0.
Measured: From first dose of study treatment until 90 days after last dose (each cycle is 21 days; up to 6 neoadjuvant cycles + up to 8 maintenance cycles; total up to approximately 12 months).
Patient-Reported Outcomes (PROs)-Change in Quality of Life as Measured by the EORTC QLQ-C30
Change from baseline in global health status/quality of life and functional/symptom scores measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). All scales range from 0 to 100. For the global health status and functional subscales, higher scores mean a better outcome. For the symptom subscales, higher scores mean a worse outcome.
Measured: Baseline (pre-treatment), and at 3, 6, 12, 24, and 36 months post-treatment. For assessments occurring during the treatment phase (each cycle is 21 days; up to 6 neoadjuvant cycles followed by up to 8 maintenance cycles).
Patient-Reported Outcomes (PROs)-Change in Cervical Cancer-Specific Symptoms as Measured by the EORTC QLQ-CX24
Change from baseline in symptom and functional scores measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module 24 (EORTC QLQ-CX24). All scales range from 0 to 100. For functional scales (including sexual activity), higher scores mean a better outcome. For symptom scales (including pain, lymphoedema, peripheral neuropathy, menopausal symptoms, and sexual worry), higher scores mean a worse outcome.
Measured: Baseline (pre-treatment), and at 3, 6, 12, 24, and 36 months post-treatment. For assessments occurring during the treatment phase (each cycle is 21 days; up to 6 neoadjuvant cycles followed by up to 8 maintenance cycles).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label, Simon's two-stage optimal design. In the first stage, 33 patients will be enrolled. If 10 or more patients achieve pathological complete response (pCR), the study will proceed to the second stage, enrolling additional patients to reach a total of 94 evaluable patients (accounting for 10% dropout, total enrollment target is 103). The primary endpoint is pCR rate
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646301
- Sponsor's protocol ID
- B2026-154-01
- Acronym
- QUARTZ-CC
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "The informed consent form approved by the ethics committee does not include provisions for sharing individual participant data with external researchers. Therefore, IPD will not be shared."
Publications
Lou H, Zhou Y, Li D, et al. 251 Efficacy and safety of iparomlimab and tuvonralimab in previously treated patients with recurrent or metastatic cervical cancer: a multicenter, open-label, single-arm, phase 2 clinical trial (DUBHE-C- 206). Int J Gynecol Cancer. 2024;34(Suppl 1):A5.1.
Pan YC, Dai Z, Ma H, Zheng J, Leng J, Xie C, Yuan Y, Yang W, Yalikun Y, Song X, Han CB, Shang C, Yang Y. Self-powered and speed-adjustable sensor for abyssal ocean current measurements based on triboelectric nanogenerators. Nat Commun. 2024 Jul 20;15(1):6133. doi: 10.1038/s41467-024-50581-w.
PubMed 39033189Cui B, Xian C, Han B, Shu C, Qian Y, Ouyang Z, Wang X. High-resolution emission inventory of biogenic volatile organic compounds for rapidly urbanizing areas: A case of Shenzhen megacity, China. J Environ Manage. 2024 Feb;351:119754. doi: 10.1016/j.jenvman.2023.119754. Epub 2023 Dec 10.
PubMed 38071916Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
PubMed 2702835
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Prospective Single-Arm Phase II Trial
- ClinicalTrials.gov ID
- NCT07646301
- Acronym / sponsor ID
- QUARTZ-CC / B2026-154-01
- Conditions
- Uterine Cervical Neoplasms, Locally Advanced
- Keywords
- Locally advanced cervical cancer, QL1706, Neoadjuvant chemoimmunotherapy, Pathological complete response, Phase II Single-arm Prospective study, QUARTZ-CC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
To evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP/TC regimen) for patients with locally advanced cervical cancer.
Eligibility Criteria:
Women aged 18 to 70 years with newly diagnosed, histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO stage IB3 or IIA2, with no evidence of significant lymph node involvement (pelvic and paraaortic lymph nodes <1.5 cm in short diameter), and who have not received any prior anticancer therapy.
Study Procedures:
Participants will receive up to 4 cycles of QL1706 plus TP/TC chemotherapy (once every 3 weeks) prior to surgery. After 2 cycles, clinical assessment will be performed to evaluate tumor response. If tumor shrinkage is observed, treatment may continue for 2 additional cycles, followed by imaging evaluation. Depending on the response, participants with complete or partial response may undergo less extensive surgery (cervical conization plus sentinel lymph node biopsy) rather than standard radical hysterectomy. After surgery, participants who achieve a major pathological response will receive QL1706 maintenance therapy as a single agent for up to 8 additional cycles (once every 3 weeks). For participants with insufficient tumor response, standard radical hysterectomy will be performed. Postoperative adjuvant therapy (radiation or chemotherapy) will follow standard clinical guidelines.
Primary and Secondary Objectives:
The primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life.
Study Duration:
Total participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).
Detailed description
Detailed Description Background Cervical cancer remains the fourth most common malignancy among women worldwide. In 2022, approximately 660,000 new cases and 350,000 deaths were reported globally, with the heaviest burden observed in developing regions, particularly Asia, which accounts for nearly 60% of global cases and deaths. China alone contributes 22.8% of global incidence and 16% of global mortality.
Locally advanced cervical cancer (LACC, FIGO stages IB3 and IIA2) constitutes approximately 50% of all cervical cancer cases in China. Current standard of care is concurrent chemoradiotherapy (CCRT); however, 23.3%-34.4% of patients still experience disease recurrence or metastasis. Neoadjuvant chemotherapy (NACT) followed by radical surgery has been investigated as an alternative strategy, yet 9.8%-30.6% of patients fail to respond to NACT, potentially delaying effective local treatment. Moreover, over 30% of patients who undergo surgery require adjuvant radiotherapy, raising concerns regarding treatment burden and health economics.In recent years, immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy. Anti-PD-1/PD-L1 and anti-CTLA-4 antibodies exert complementary mechanisms of action. Emerging evidence supports the combination of neoadjuvant chemotherapy and immunotherapy for LACC. In the PACS study (presented at ASCO 2024), the pathological complete response (pCR) rate was 36.2%, and the optimal pathological response rate (residual tumor <3 mm) was 53.2%. Other studies, including NACI, MITO CERV3, and NATCI, have reported similarly encouraging pCR rates. Given the unmet medical need for more effective and less toxic neoadjuvant regimens, further evaluation of novel immunotherapy combinations such as the dual PD-1/CTLA-4 bispecific antibody iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy is warranted.
Detailed Treatment and Response-Adapted Algorithm Following neoadjuvant treatment (up to 4 cycles of paclitaxel plus cisplatin or carboplatin combined with QL1706), patients undergo clinical assessment after 2 cycles. If tumor shrinkage is observed, patients continue for 2 additional cycles followed by imaging evaluation. Based on imaging response: complete response leads to cervical conization plus sentinel lymph node biopsy or pelvic lymph node dissection; partial response leads to radical hysterectomy or trachelectomy plus sentinel lymph node biopsy or pelvic lymph node dissection. Patients achieving optimal pathological response (defined as pathological complete response or residual tumor depth ≤3 mm) receive 2 additional cycles of the same regimen followed by QL1706 maintenance therapy for 8 cycles. Non-optimal responders receive adjuvant therapy per NCCN guidelines. Patients who cannot tolerate surgery or have contraindications receive radical radiotherapy.
Sample Size Justification and Statistical Framework The sample size was calculated using Simon's two-stage optimal design (one-sided alpha=0.05, power=80%; null hypothesis pCR=30% vs. alternative pCR=43%). The first stage enrolls 33 patients; if 10 or more pCR events are observed, enrollment continues to a total of 94 evaluable patients. Accounting for 10% dropout, total target enrollment is 103 patients.
Data and Safety Monitoring An independent Data Monitoring Committee will oversee patient safety and conduct periodic reviews. The Committee may recommend early termination for efficacy, futility, or safety concerns. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, with written informed consent obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label, Simon's two-stage optimal design. In the first stage, 33 patients will be enrolled. If 10 or more patients achieve pathological complete response (pCR), the study will proceed to the second stage, enrolling additional patients to reach a total of 94 evaluable patients (accounting for 10% dropout, total enrollment target is 103). The primary endpoint is pCR rate
| Arm | Type | Receives |
|---|---|---|
| QL1706 + TP/TC Neoadjuvant Chemoimmunotherapy | Experimental | Drug: Iparomlimab and Tuvonralimab (QL1706), Drug: Paclitaxel, Drug: Cisplatin, Drug: CarboplatinParticipants receive up to 4 cycles of neoadjuvant therapy (once every 3 weeks) with iparomlimab and tuvonralimab (QL1706 250 mg, IV) plus paclitaxel (150-175 mg/m², IV) and either cisplatin (70-75 mg/m², IV, split over 2 days) or carboplatin (AUC=5, IV). Treatment response is assessed after 2 cycles. For patients achieving tumor shrinkage, neoadjuvant therapy continues for 2 additional cycles followed by imaging. Patients achieving complete response (CR) undergo cervical conization plus sentinel lymph node biopsy (SLNB) or pelvic lymph node dissection (PLND). Those achieving partial response (PR) or non-optimal pathological response after surgery undergo radical hysterectomy/trachelectomy plus SLNB/PLND. Participants who achieve optimal pathological response (pCR or residual tumor depth ≤3 mm) after surgery receive QL1706 maintenance therapy for up to 8 cycles (once every 3 weeks). Patients who cannot tolerate surgery or have contraindications undergo radical radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70 years.
- Histologically or cytologically confirmed cervical cancer, FIGO stage IB3 or IIA2.
- Imaging findings showing pelvic lymph node short-axis diameter < 1.5 cm and para-aortic lymph node short-axis diameter < 1.5 cm.
- Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- No prior anti-tumor therapy.
Key exclusion criteria (16 listed)
- Presence of other concurrent malignancies.
- Pregnant or peripartum women.
- History of myocardial infarction or stroke, unstable angina, decompensated heart failure, or deep vein thrombosis.
- Presence of NCI-CTCAE version 5.0 grade ≥2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Active unresolved hepatitis, defined as progressive decrease in appetite, general weakness, nausea, acid reflux, aversion to oily foods, abdominal distension, or abnormal liver function with jaundice (e.g., scleral or urinary jaundice); for hepatitis B, HBV DNA > 1000 IU/mL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706)250 mg administered intravenously over at least 30 minutes on Day 1 of each 21-day cycle for up to 4 cycles as neoadjuvant therapy, and up to 8 cycles as maintenance therapy (for patients achieving optimal pathological response). | Drug | QL1706 + TP/TC Neoadjuvant Chemoimmunotherapy |
| Paclitaxel150-175 mg/m² administered intravenously over at least 3 hours on Day 1 of each 21-day cycle for up to 4 cycles, with standard premedication to prevent hypersensitivity. | Drug | QL1706 + TP/TC Neoadjuvant Chemoimmunotherapy |
| Cisplatin70-75 mg/m² administered intravenously over at least 1 hour, split over two consecutive days (Day 1 and Day 2) of each 21-day cycle for up to 4 cycles. Cisplatin or Carboplatin according to investigator's choice | Drug | QL1706 + TP/TC Neoadjuvant Chemoimmunotherapy |
| CarboplatinAUC=5 administered intravenously over at least 1 hour on Day 1 of each 21-day cycle for up to 4 cycles. Cisplatin or Carboplatin according to investigator's choice | Drug | QL1706 + TP/TC Neoadjuvant Chemoimmunotherapy |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days; patients receive 2 to 4 cycles)
Proportion of patients with no residual invasive tumor cells in the surgically resected primary tumor specimen following neoadjuvant therapy.
7 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days)
Objective Response Rate (ORR)
Time frame: After 4 cycles of neoadjuvant treatment (each cycle is 21 days)
3-Year Overall Survival (OS) Rate
Time frame: From date of first dose to date of death from any cause, assessed up to 36 months
3-Year Disease-Free Survival (DFS) Rate
Time frame: From date of surgery to date of recurrence or death, assessed up to 36 months
Treatment-Related Adverse Events (TRAEs)
Time frame: From first dose of study treatment until 90 days after last dose (each cycle is 21 days; up to 6 neoadjuvant cycles + up to 8 maintenance cycles; total up to approximately 12 months).
Patient-Reported Outcomes (PROs)-Change in Quality of Life as Measured by the EORTC QLQ-C30
Time frame: Baseline (pre-treatment), and at 3, 6, 12, 24, and 36 months post-treatment. For assessments occurring during the treatment phase (each cycle is 21 days; up to 6 neoadjuvant cycles followed by up to 8 maintenance cycles).
Patient-Reported Outcomes (PROs)-Change in Cervical Cancer-Specific Symptoms as Measured by the EORTC QLQ-CX24
Time frame: Baseline (pre-treatment), and at 3, 6, 12, 24, and 36 months post-treatment. For assessments occurring during the treatment phase (each cycle is 21 days; up to 6 neoadjuvant cycles followed by up to 8 maintenance cycles).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publicationLou H, Zhou Y, Li D, et al. 251 Efficacy and safety of iparomlimab and tuvonralimab in previously treated patients with recurrent or metastatic cervical cancer: a multicenter, open-label, single-arm, phase 2 clinical trial (DUBHE-C- 206). Int J Gynecol Cancer. 2024;34(Suppl 1):A5.1.
- Results publication: PubMed 39033189Pan YC, Dai Z, Ma H, Zheng J, Leng J, Xie C, Yuan Y, Yang W, Yalikun Y, Song X, Han CB, Shang C, Yang Y. Self-powered and speed-adjustable sensor for abyssal ocean current measurements based on triboelectric nanogenerators. Nat Commun. 2024 Jul 20;15(1):6133. doi: 10.1038/s41467-024-50581-w.
- Results publication: PubMed 38071916Cui B, Xian C, Han B, Shu C, Qian Y, Ouyang Z, Wang X. High-resolution emission inventory of biogenic volatile organic compounds for rapidly urbanizing areas: A case of Shenzhen megacity, China. J Environ Manage. 2024 Feb;351:119754. doi: 10.1016/j.jenvman.2023.119754. Epub 2023 Dec 10.
- Results publication: PubMed 2702835Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
- Individual participant dataSharing planned: No. "The informed consent form approved by the ethics committee does not include provisions for sharing individual participant data with external researchers. Therefore, IPD will not be shared."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706), Paclitaxel and Cisplatin in people with Uterine Cervical Neoplasms and Locally Advanced, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihong Liu, Ph.D. (+86 20 87341779, liujih@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days; patients receive 2 to 4 cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07646301, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.