💬In plain words
What the trial is, and whether it could suit you
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 s
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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