OncoMatch/Clinical Trials/NCT07646301
Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
Is NCT07646301 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies multiple treatments including Iparomlimab and Tuvonralimab (QL1706) and Paclitaxel for uterine cervical neoplasms.
Treatment: Iparomlimab and Tuvonralimab (QL1706) · Paclitaxel · Cisplatin · Carboplatin — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Cervical Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Lab requirements
Blood counts
coagulation abnormality (INR > 2.0, PT > 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy excluded (prophylactic low-dose aspirin and low-molecular-weight heparin permitted)
Kidney function
serum creatinine ≤ 2 × upper limit of normal; renal insufficiency excluded
Liver function
aspartate aminotransferase/alanine aminotransferase ≤ 2.5 × upper limit of normal; hepatic insufficiency excluded
Cardiac function
history of myocardial infarction or stroke, unstable angina, decompensated heart failure, or deep vein thrombosis excluded; NCI-CTCAE v5.0 grade ≥2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention excluded
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. Hepatic insufficiency (aspartate aminotransferase/alanine aminotransferase > 2.5 × upper limit of normal). Renal insufficiency (serum creatinine > 2 × upper limit of normal). 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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07646301 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages