Neoadjuvant Treatment for Locally Advanced Cervical CancerPhase 2NCT07286253
QL1706 Plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Phase II Trial
A Phase 2 study testing Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W in people with Neoadjuvant Treatment for Locally Advanced Cervical Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
Cervical cancer ranks as the second most common malignancy of the female genital tract. According to the World Health Organization, there are 530,000 new cases and approximately 250,000 cervical-cancer-related deaths worldwide each year, with 80% of these deaths occurring in women from developing countries. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Neoadjuvant Treatment for Locally Advanced Cervical Cancer
- What is being tested?
- Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to 30 Mar 2028
- 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
- (1) Has given written informed consent (or consent provided by an immediate family member if the subject is unable to do so) after full explanation of the study.
- Female, aged ≥ 18 and ≤ 70 years on the date of informed-consent signature. (3) Histologically confirmed cervical cancer: A. Squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; B. Previously untreated-no prior anti-cancer therapy for cervical cancer; C. FIGO 2018 stage IB3 or IIA2; D. Stage IIICr without involvement of the lower third of the vagina and without parametrial infiltration.
- At least one measurable lesion by CT or MRI per RECIST 1.1. Note: Lesions situated in a prior radiation field or previously treated by local-regional therapy must be classified as non-target lesions unless clear progression is documented or tumor viability is confirmed by biopsy, and no other measurable lesion exists; in that case the lesion may serve as a target lesion.
- Archival tumor tissue obtained within 5 years before enrollment OR a freshly obtained biopsy (≈ 7 unstained FFPE slides, minimum 5; preference for recent sample).
- The biopsied lesion must not be selected as a RECIST 1.1 target lesion unless no other site is suitable and the biopsy was performed outside the screening period. If a subject cannot provide the required slides and the investigator judges re-biopsy to be unsafe, the number of slides may be reduced at the investigator's discretion.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. (7) Life expectancy ≥ 12 weeks. (8) Adequate function of major organs documented within 14 days before randomisation (no transfusion, albumin, recombinant human thrombopoietin or colony-stimulating factors allowed during this period): Haematology Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelets ≥100 × 10⁹/L Haemoglobin ≥90 g/L Hepatic Total bilirubin ≤1.5 × upper limit of normal (ULN) ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present) Serum albumin ≥30 g/L Renal Serum creatinine ≤1.5 × ULN; OR if >1.5 × ULN, calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault) Coagulation APTT ≤1.5 × ULN PT/INR ≤1.5 × ULN Cardiac Left-ventricular ejection fraction (LVEF) ≥50% Urinalysis Dipstick proteinuria <2+ If ≥2+, 24-hour urine protein must be <1.0 g to permit entry (9) Women of child-bearing potential must use a highly effective contraceptive method from informed-consent signature until 180 days after the last study-dose administration and must not be pregnant or lactating.
Who cannot join
- (1) Prior exposure to any immunotherapy, including immune-checkpoint inhibitory antibodies (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4), immune-checkpoint agonistic antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40), or cellular immunotherapy.
- Systemic or severe infection requiring intravenous antibiotics for >7 days within 2 weeks before enrolment, or unexplained fever >38.5 °C detected during screening or within 2 weeks prior to enrolment (fever judged by the investigator to be tumour-related is permitted).
- Systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors) for any indication within 2 weeks before enrolment. Topical, nasal or inhaled corticosteroids are allowed; systemic steroids given solely for prophylaxis of contrast allergy are also permitted.
- Treatment with immunomodulatory agents such as thymosin, lentinan, interferon or interleukins within 2 weeks before enrolment.
- Use within 2 weeks before enrolment of aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine, cilostazol, or any therapeutic-dose anticoagulant other than low-molecular-weight heparin.
- Use of modern Chinese herbal preparations approved by NMPA for anti-cancer therapy within 2 weeks before enrolment.
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- Major surgery, open biopsy or significant traumatic injury within 4 weeks before enrolment; or planned elective major surgery during the study. Local invasive procedures (e.g., core biopsy) within 1 week before enrolment are excluded, except for vascular-access device placement.
- Anti-cancer therapy (chemotherapy, endocrine therapy, targeted therapy, biological therapy, trans-arterial chemo-embolisation, etc.) within 4 weeks before enrolment.
- Symptomatic CNS metastases, leptomeningeal disease or spinal-cord compression at baseline. Asymptomatic subjects with stable CNS disease who have completed any prior CNS-directed therapy ≥2 weeks earlier and have been off corticosteroids and anti-convulsants for ≥2 weeks may be enrolled.
- Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting.
- Recurrent third-space fluid (e.g., pleural effusion or ascites) requiring repeated drainage and judged poorly controlled.
- Active or potentially relapsing autoimmune disease, except: vitiligo, alopecia, psoriasis or eczema not requiring systemic therapy; hypothyroidism due to autoimmune thyroiditis on stable hormone replacement; or type 1 diabetes on stable-dose insulin.
- History of gastrointestinal or genitourinary perforation/fistula, or intra-abdominal abscess within 6 months before enrolment (subjects are eligible if the underlying defect has been surgically corrected).
- Bowel obstruction within 6 months before enrolment (subjects with incomplete obstruction that has resolved after treatment may be enrolled at the investigator's discretion), active intra-abdominal inflammation (including but not limited to peptic ulcer, diverticulitis or colitis).
- Clinically significant cardiovascular disorders:
- Myocardial infarction, unstable angina, pulmonary embolism or other arterial/venous thrombo-embolic or cerebrovascular event requiring medical intervention within 6 months before enrolment;
- NYHA class III-IV congestive heart failure;
- Serious arrhythmia requiring medication;
- Mean QTcF >470 ms on 12-lead ECG (Fridericia formula) at screening. (16) Co-existing conditions that would increase the risk of adverse events during the study:
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- Poorly controlled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) despite optimal therapy;
- Prior hypertensive crisis or hypertensive encephalopathy;
- History of intracranial or spinal haemorrhage;
- Bleeding diathesis, severe coagulopathy (off anticoagulation) or tumour encasing major vessels;
- Haemoptysis ≥½ teaspoon bright-red blood per episode, radiation enteritis/colitis or radiation cystitis with bleeding within 3 months before enrolment;
- Evidence of free intra-abdominal air;
- Serious non-healing or dehiscent wound or untreated fracture;
- Any other condition judged by the investigator to confer unacceptable risk. (17) Interstitial lung disease, pneumoconiosis, drug-related pneumonitis or severely impaired pulmonary function that might interfere with detection or management of suspected drug-related pulmonary toxicity.
- HIV-positive; active hepatitis B (HBsAg-positive and HBV-DNA >500 IU/mL, or above local lower limit of detection if >500 IU/mL); active hepatitis C (subjects with positive HCV antibody but HCV-RNA below local lower limit of detection are eligible).
- Known active tuberculosis; known active syphilis. (20) Other active malignancy within 5 years before informed consent, except adequately treated localised cancers (e.g., basal- or squamous-cell skin cancer, superficial bladder cancer, ductal carcinoma in situ of the breast).
- Prior allogeneic haematopoietic stem-cell or organ transplantation (corneal transplant allowed).
- Live-vaccine administration within 4 weeks before enrolment. (23) Participation in another clinical trial and receipt of an investigational product within 4 weeks before enrolment.
- History of substance abuse (drugs or alcohol) or psychiatric/neurological disorder (epilepsy, dementia, hepatic encephalopathy, etc.) that could compromise compliance.
- Known hypersensitivity to macromolecular protein preparations, or contraindication/allergy to any component of QL1706, cisplatin/carboplatin or paclitaxel.
- Any condition that, in the opinion of the investigator, could increase study-related risk or interfere with interpretation of results.
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
Lipai Chen
Guangzhou, Guangdong
chen lipai, 13556170919, chenlipai@163.com
About this study
Official title: A Single-arm, Multicenter Phase II Clinical Study of QL1706 Plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cance
Cervical cancer ranks as the second most common malignancy of the female genital tract. According to the World Health Organization, there are 530,000 new cases and approximately 250,000 cervical-cancer-related deaths worldwide each year, with 80% of these deaths occurring in women from developing countries. Early-stage disease can be managed surgically, whereas advanced or recurrent cervical cancer is treated with individualized multimodal therapy; nevertheless, the optimal management of locally advanced cervical cancer (FIGO 2018 stage IB3-IIA2) remains controversial. Chemoradiation is standard, but neoadjuvant chemotherapy followed by radical surgery after tumor down-staging is also used. More than 90% of cervical cancers are driven by persistent infection with high-risk human papillomavirus (HPV), which evades host immunity in part by up-regulating PD-L1 on tumor cells. Published series report PD-L1 positivity in 34.4-96% of cervical cancers, with even higher rates in squamous-cell histology, providing a rationale for PD-1/PD-L1 blockade. QL1706, a novel bispecific immunotherapeutic agent, has recently been approved as monotherapy for second-line treatment of advanced cervical cancer.QL1706, developed by Qilu Pharmaceutical using the proprietary MabPair™ platform, is the first bispecific antibody simultaneously targeting PD-1 and CTLA-4, showing synergistic anti-tumor activity and favorable tolerability.Unlike previous phase II/III trials of PD-1 monotherapy, this study does not restrict enrolment to patients with PD-L1-positive tumors, so QL1706 is expected to confer benefit in the second-line management of recurrent or metastatic cervical cancer. Therefore, investigating QL1706-based combination regimens as neoadjuvant treatment for treatment-naïve disease is also highly relevant and may improve outcomes in women with locally advanced cervical cancer.
- Being tested
- Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3WDrug
Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Experimental: QL1706 plus nab-paclitaxel plus cisplatin/carboplatin | Experimental | Not described Receives: Drug: Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR)
Pathological complete response (pCR) is defined as the absence of residual malignant tumor cells in the resected specimen.
Measured: 2 years
Secondary outcomes (3)
Objective response rate (ORR)
The ratio of patients who are evaluated as CR or PR
Measured: 2 years
Disease-free survival (DFS)
defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first.
Measured: 2 years
2-year disease-free survival rate (2-year DFS rate)
2-year disease-free survival rate (2-year DFS rate): defined as the proportion of participants who remain alive and without radiologically documented disease progression at 2 years from enrollment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start28 Oct 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant Treatment for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lipai Chen, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286253
- Sponsor's protocol ID
- QL-CC-QIBA-3005
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Phase II Clinical Study of QL1706 Plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cance
- ClinicalTrials.gov ID
- NCT07286253
- Acronym / sponsor ID
- QL-CC-QIBA-3005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 16 Dec 2025 (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.
Cervical cancer ranks as the second most common malignancy of the female genital tract. According to the World Health Organization, there are 530,000 new cases and approximately 250,000 cervical-cancer-related deaths worldwide each year, with 80% of these deaths occurring in women from developing countries. Early-stage disease can be managed surgically, whereas advanced or recurrent cervical cancer is treated with individualized multimodal therapy; nevertheless, the optimal management of locally advanced cervical cancer (FIGO 2018 stage IB3-IIA2) remains controversial. Chemoradiation is standard, but neoadjuvant chemotherapy followed by radical surgery after tumor down-staging is also used. More than 90% of cervical cancers are driven by persistent infection with high-risk human papillomavirus (HPV), which evades host immunity in part by up-regulating PD-L1 on tumor cells. Published series report PD-L1 positivity in 34.4-96% of cervical cancers, with even higher rates in squamous-cell histology, providing a rationale for PD-1/PD-L1 blockade. QL1706, a novel bispecific immunotherapeutic agent, has recently been approved as monotherapy for second-line treatment of advanced cervical cancer.QL1706, developed by Qilu Pharmaceutical using the proprietary MabPair™ platform, is the first bispecific antibody simultaneously targeting PD-1 and CTLA-4, showing synergistic anti-tumor activity and favorable tolerability.Unlike previous phase II/III trials of PD-1 monotherapy, this study does not restrict enrolment to patients with PD-L1-positive tumors, so QL1706 is expected to confer benefit in the second-line management of recurrent or metastatic cervical cancer. Therefore, investigating QL1706-based combination regimens as neoadjuvant treatment for treatment-naïve disease is also highly relevant and may improve outcomes in women with locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: QL1706 plus nab-paclitaxel plus cisplatin/carboplatin | Experimental | Drug: Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W |
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)
- (1) Has given written informed consent (or consent provided by an immediate family member if the subject is unable to do so) after full explanation of the study.
- The biopsied lesion must not be selected as a RECIST 1.1 target lesion unless no other site is suitable and the biopsy was performed outside the screening period. If a subject cannot provide the required slides and the investigator judges re-biopsy to be unsafe, the number of slides may be reduced at the investigator's discretion.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. (7) Life expectancy ≥ 12 weeks. (8) Adequate function of major organs documented within 14 days before randomisation (no transfusion, albumin, recombinant human thrombopoietin or colony-stimulating factors allowed during this period): Haematology Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelets ≥100 × 10⁹/L Haemoglobin ≥90 g/L Hepatic Total bilirubin ≤1.5 × upper limit of normal (ULN) ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present) Serum albumin ≥30 g/L Renal Serum creatinine ≤1.5 × ULN; OR if >1.5 × ULN, calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault) Coagulation APTT ≤1.5 × ULN PT/INR ≤1.5 × ULN Cardiac Left-ventricular ejection fraction (LVEF) ≥50% Urinalysis Dipstick proteinuria <2+ If ≥2+, 24-hour urine protein must be <1.0 g to permit entry (9) Women of child-bearing potential must use a highly effective contraceptive method from informed-consent signature until 180 days after the last study-dose administration and must not be pregnant or lactating.
Key exclusion criteria (35 listed)
- (1) Prior exposure to any immunotherapy, including immune-checkpoint inhibitory antibodies (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4), immune-checkpoint agonistic antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40), or cellular immunotherapy.
- <!-- -->
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 |
|---|---|---|
| Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3WDrug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W | Drug | Experimental: QL1706 plus nab-paclitaxel plus cisplatin/carboplatin |
Primary outcome
Pathological complete response (pCR)
Time frame: 2 years
Pathological complete response (pCR) is defined as the absence of residual malignant tumor cells in the resected specimen.
3 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
Disease-free survival (DFS)
Time frame: 2 years
2-year disease-free survival rate (2-year DFS rate)
Time frame: 2 years
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 16 Dec 2025.
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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 Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W in people with Neoadjuvant Treatment for Locally Advanced Cervical Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical 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 35 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 16 Dec 2025. 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 chen lipai (13556170919, chenlipai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.