Cervical CancerPhase 2NCT06942416
Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer
A Phase 2 study testing Paclitaxel and Cisplatin/ Carboplatin, Iparomlimab and Tuvonralimab and Radiotherapy in people with Cervical Cancer and Neoplasm Recurrence, Local, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin/carboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer, Neoplasm Recurrence, Local, Oligometastatic
- What is being tested?
- Paclitaxel and Cisplatin/ Carboplatin, Iparomlimab and Tuvonralimab and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to 31 Dec 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent prior to any trial-related procedures;
- Female, aged ≥18 and ≤75 years;
- ECOG PS 0-1;
- Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria;
- Locally recurrent or oligometastatic cervical cancer after initial treatment. Total recurrent + metastatic lesions ≤5.Oligometastasis criteria:Lymph node metastases within the same region = 1 lesion;Liver metastases ≤1 lesion;Lung metastases ≤3 lesions
- At least one measurable lesion (including primary lesion) suitable for radiotherapy and evaluable per RECIST v1.1;
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- Available tumor tissue sample for biomarker assessment;
- Expected survival ≥6 months;
- Normal organ function (within 7 days pre-enrollment):
- Hematological criteria (no transfusion/granulocyte/platelet-stimulating drugs within 14 days):
- Hemoglobin (Hb) ≥80 g/L
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L
- Platelets (PLT) ≥50×10⁹/L (2) No functional organic disease:
- ALT/AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, ALP ≤3×ULN, albumin ≥30 g/L b) Serum Cr ≤1.5×ULN (if >1.5×ULN, CrCl ≥50 mL/min by Cockcroft-Gault formula) c) PT prolongation ≤6 sec, APTT ≤1.5×ULN d) TSH ≤ULN (if abnormal, FT3/FT4 must be normal) f) LVEF >50% 10. Prior anti-tumor treatment toxicities recovered to ≤Grade 1 (CTCAE v5.0) pre-treatment, excluding:
- Alopecia/pigmentation (any grade)
- Peripheral neuropathy (≤Grade 2)
- Other toxicities where benefit-risk favors treatment 11. Non-sterilized/childbearing-potential females must:
- Use medical contraception (IUD/oral contraceptives/condoms) during treatment + 3 months post-treatment
- Negative serum/urine HCG within 7 days pre-enrollment
- Non-lactating 12. Expected compliance with protocol follow-up following criteria:
- Prior immunotherapy (e.g., immune checkpoint inhibitors);
- Pathological diagnosis of gastric-type adenocarcinoma;
- Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions: vitiligo; childhood asthma fully resolved without intervention in adulthood. Exclusion: asthma requiring bronchodilator therapy;
- Current use of immunosuppressants or systemic/absorbable topical corticosteroids (equivalent to >10 mg/day prednisone) for immunosuppression, continued within 2 weeks before enrollment;
- History of Grade 3-4 immune-related adverse events (irAEs) associated with prior anti-tumor immunotherapy;
- Poorly controlled cardiac conditions:
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- NYHA Class II or higher heart failure
- Unstable angina
- Myocardial infarction within 6 months
- Clinically significant supraventricular/ventricular arrhythmia requiring treatment
- QTc >450 ms (males) or >470 ms (females); 7. Coagulation abnormalities (INR >1.5 or PT >16 s), bleeding tendency, or current thrombolytic/anticoagulant therapy; 8. Prior radiotherapy/chemotherapy/hormonal therapy/surgery/targeted therapy completed <4 weeks before study treatment (or <5 drug half-lives, whichever is longer); unresolved toxicities (excluding alopecia) from prior therapies >CTCAE Grade 1; 9. Poorly controlled third-space effusion requiring drainage before first trial drug administration; 10. Significant hemoptysis (≥2.5 mL/day) within 2 months before randomization; 11. Known hereditary/acquired bleeding/thrombotic disorders (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism); 12. Active infection or unexplained fever >38.5°C during screening/before first dose; 13. Objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction; 14. Immunodeficiency (e.g., HIV infection) or active hepatitis:
- HBV DNA > upper limit of normal (ULN)
- HCV RNA > ULN; 15. Use of other investigational drugs within 4 weeks before first dose; radiotherapy/local therapy within 2 weeks without full recovery; 16. Concurrent/prior malignancies (except cured basal cell carcinoma/cervical carcinoma in situ); 17. Planned concurrent systemic anti-tumor therapy during the study; 18. Live vaccination within 4 weeks before treatment or planned during the study; 19. Other conditions potentially requiring study termination per investigator judgment:
- Severe comorbidities (including psychiatric disorders) requiring treatment
- Critical lab abnormalities
- Social/family factors compromising safety or data/sample collection.
Who cannot join
None listed.
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
Shandong Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong Recruiting
Jing Liu
About this study
Official title: Phase II, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab in Combination With Paclitaxel Plus Cisplatin/Carboplatin and Radiotherapy for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer
The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin/carboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are:
- Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?
- What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?
Read more
Participants will:
- Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin/Carboplatin and radiation therapy according to a specified protocol.
- Visit the clinic for regular checkups and tests throughout the treatment period.
- Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.
- Provide hematologic、tissue and stool samples to explore biomarkers.
This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.
- Conditions
- Cervical Cancer, Neoplasm Recurrence, Local, Oligometastatic
- Being tested
- Paclitaxel and Cisplatin/ Carboplatin, Iparomlimab and Tuvonralimab, Radiotherapy
- Keywords
- Immunotherapy, Paclitaxel, Cisplatin, Carboplatin, Radiation Therapy, Clinical Trials, Phase II as Topic, Progression-Free Survival, Biomarkers, Tumor, Treatment Outcome, Safety, Iparomlimab and Tuvonralimab
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasm Recurrence, Local, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel and Cisplatin/ CarboplatinDrug
Paclitaxel and Cisplatin Paclitaxel: 135 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W). Cisplatin: 75 mg/m², intravenous infusion, Days 1-3, every 3 weeks (Q3W). Carboplatin 0.3-0.4g/m², intravenous infusion, Day 1, Q3W .Duration: 4-6 cycles.
Iparomlimab and TuvonralimabDrug
Iparomlimab and Tuvonralimab 5mg/kg, intravenous infusion, Day 1, Q3W. Duration: Continuous administration until disease progression, death, intolerable toxicity, subject's voluntary withdrawal, investigator's decision for withdrawal, or a maximum of 24 months.
RadiotherapyRadiation
Site Selection: Original site, lymph nodes, lung metastasis, bone metastasis, adrenal metastasis, brain metastasis, and other relatively isolated, well-vascularized lesions. Select at least one suitable lesion for radiotherapy based on the impact of the recurrent or metastatic lesion on the body, prioritizing lesions that cause symptoms, are life-threatening, or are expected to cause symptoms.All tumor lesions will be irradiated, which can be done in phases. Dosage and Fractionation: Conventional or hypofractionated radiotherapy, with a biologically effective dose (BED) of ≥ 72 Gy. Dose adjustments can be made for brain metastases. Timing: After completing relevant baseline examinations, radiotherapy can be implemented generally after 4-6 cycles of systemic therapy, or after the first cycle for small, solitary metastatic lesions. echnique: IMRT, TOMO, SBRT, 3D-BT, interstitial implantation therapy, or proton therapy.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy+Immunotherapy+Radiotherapy | Experimental | Chemotherapy：TP (Paclitaxel and Cisplatin/Carboplatin); Immunotherapy：Iparomlimab and Tuvonralimab;Radiotherapy：All tumor lesions will be irradiated Receives: Drug: Paclitaxel and Cisplatin/ Carboplatin; Drug: Iparomlimab and Tuvonralimab; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first.
Measured: Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months
Secondary outcomes (4)
Objective Response Rate
ORR refers to the proportion of patients whose optimal response is complete or partial response
Measured: Assessed every 6 weeks via imaging until study completion (up to 24 months
Overall Survival
The time interval from enrollment to death from any cause
Measured: The time interval from enrollment to death from any cause, assessed up to 60 months
Disease Control Rate
DCR refers to the proportion of patients whose optimal response is complete or partial response, or stable disease
Measured: Assessed every 6 weeks via imaging until study completion (up to 24 months）
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with adverse events and severe as assessed by CTCAE v5.
Measured: Before each chemotherapy cycle (each cycle is 21 days), at 24 hours pre- and post-radiotherapy, and every 3 months during follow-up (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start28 Feb 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Xie, Shandong Cancer Hospital and Institute
- Investigators
- Peng Xie, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942416
- Sponsor's protocol ID
- SDZLEC2025-028-02
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab in Combination With Paclitaxel Plus Cisplatin/Carboplatin and Radiotherapy for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT06942416
- Acronym / sponsor ID
- SDZLEC2025-028-02
- Conditions
- Cervical Cancer, Neoplasm Recurrence, Local, Oligometastatic
- Keywords
- Immunotherapy, Paclitaxel, Cisplatin, Carboplatin, Radiation Therapy, Clinical Trials, Phase II as Topic, Progression-Free Survival, Biomarkers, Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Apr 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.
The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin/carboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are:
- Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?
- What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?
Participants will:
- Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin/Carboplatin and radiation therapy according to a specified protocol.
- Visit the clinic for regular checkups and tests throughout the treatment period.
- Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.
- Provide hematologic、tissue and stool samples to explore biomarkers.
This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy+Immunotherapy+Radiotherapy | Experimental | Drug: Paclitaxel and Cisplatin/ Carboplatin, Drug: Iparomlimab and Tuvonralimab, Radiation: RadiotherapyChemotherapy：TP (Paclitaxel and Cisplatin/Carboplatin); Immunotherapy：Iparomlimab and Tuvonralimab;Radiotherapy：All tumor lesions will be irradiated |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Signed written informed consent prior to any trial-related procedures;
- Female, aged ≥18 and ≤75 years;
- ECOG PS 0-1;
- Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria;
- Locally recurrent or oligometastatic cervical cancer after initial treatment. Total recurrent + metastatic lesions ≤5.Oligometastasis criteria:Lymph node metastases within the same region = 1 lesion;Liver metastases ≤1 lesion;Lung metastases ≤3 lesions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Paclitaxel and Cisplatin/ CarboplatinPaclitaxel and Cisplatin Paclitaxel: 135 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W). Cisplatin: 75 mg/m², intravenous infusion, Days 1-3, every 3 weeks (Q3W). Carboplatin 0.3-0.4g/m², intravenous infusion, Day 1, Q3W .Duration: 4-6 cycles. | Drug | Chemotherapy+Immunotherapy+Radiotherapy |
| Iparomlimab and TuvonralimabIparomlimab and Tuvonralimab 5mg/kg, intravenous infusion, Day 1, Q3W. Duration: Continuous administration until disease progression, death, intolerable toxicity, subject's voluntary withdrawal, investigator's decision for withdrawal, or a maximum of 24 months. | Drug | Chemotherapy+Immunotherapy+Radiotherapy |
| RadiotherapySite Selection: Original site, lymph nodes, lung metastasis, bone metastasis, adrenal metastasis, brain metastasis, and other relatively isolated, well-vascularized lesions. Select at least one suitable lesion for radiotherapy based on the impact of the recurrent or metastatic lesion on the body, prioritizing lesions that cause symptoms, are life-threatening, or are expected to cause symptoms.All tumor lesions will be irradiated, which can be done in phases. Dosage and Fractionation: Conventional or hypofractionated radiotherapy, with a biologically effective dose (BED) of ≥ 72 Gy. Dose adjustments can be made for brain metastases. Timing: After completing relevant baseline examinations, radiotherapy can be implemented generally after 4-6 cycles of systemic therapy, or after the first cycle for small, solitary metastatic lesions. echnique: IMRT, TOMO, SBRT, 3D-BT, interstitial implantation therapy, or proton therapy. | Radiation | Chemotherapy+Immunotherapy+Radiotherapy |
Primary outcome
Progression-Free Survival
Time frame: Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months
Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first.
4 secondary outcomes
Objective Response Rate
Time frame: Assessed every 6 weeks via imaging until study completion (up to 24 months
Overall Survival
Time frame: The time interval from enrollment to death from any cause, assessed up to 60 months
Disease Control Rate
Time frame: Assessed every 6 weeks via imaging until study completion (up to 24 months）
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Before each chemotherapy cycle (each cycle is 21 days), at 24 hours pre- and post-radiotherapy, and every 3 months during follow-up (up to 24 months)
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 24 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
Peng Xie principal investigator
Shandong Cancer Hospital and Institute
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 Paclitaxel and Cisplatin/ Carboplatin, Iparomlimab and Tuvonralimab and Radiotherapy in people with Cervical Cancer and Neoplasm Recurrence, Local, run by Shandong Cancer Hospital and Institute 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 37 inclusion and 0 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 24 Apr 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 Jing liu (+8613065077425, 13065077425@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months). 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 24 Apr 2025.