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RECRUITING

NCT07646301

PHASE2

Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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. 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).

Official title: Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Prospective Single-Arm Phase II Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2026-07-01

Completion Date

2029-07-01

Last Updated

2026-06-12

Healthy Volunteers

Conditions

Uterine Cervical Neoplasms Locally Advanced

Interventions

DRUG

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

Paclitaxel

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.

DRUG

Cisplatin

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

DRUG

Carboplatin

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

Inclusion Criteria: 1. Age 18 to 70 years. 2. Histologically or cytologically confirmed cervical cancer, FIGO stage IB3 or IIA2. 3. Imaging findings showing pelvic lymph node short-axis diameter \< 1.5 cm and para-aortic lymph node short-axis diameter \< 1.5 cm. 4. Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 5. No prior anti-tumor therapy. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Exclusion Criteria: 1. Presence of other concurrent malignancies. 2. Pregnant or peripartum women. 3. History of myocardial infarction or stroke, unstable angina, decompensated heart failure, or deep vein thrombosis. 4. 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. 5. 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. 6. Hepatic insufficiency (aspartate aminotransferase/alanine aminotransferase \> 2.5 × upper limit of normal). 7. Renal insufficiency (serum creatinine \> 2 × upper limit of normal). 8. History of chronic pulmonary disease with restrictive respiratory dysfunction. 9. History of major organ transplantation or autoimmune disease. 10. History of severe mental illness or cerebral dysfunction. 11. History of substance abuse or drug addiction. 12. 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. 13. 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). 14. Congenital or acquired immunodeficiency (e.g., HIV infection). 15. Receipt of inactivated vaccine within 30 days prior to the first dose of study treatment. 16. Inability or unwillingness to provide written informed consent or comply with study requirements.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China