Dual PD1/CTLA4 immunotherapy with chemotherapy before surgery for locally advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm Phase 2 trial evaluates neoadjuvant therapy consisting of QL1706 (iparomlimab and tuvonralimab) plus paclitaxel with either cisplatin or carboplatin (TP/TC) given every 3 weeks for up to four cycles before radical surgery. Patients will have imaging and clinical assessments after 2 cycles to gauge response, with the possibility of two additional cycles if there is tumor shrinkage. Eligible participants are women aged 18–70 with newly diagnosed, histologically confirmed cervical cancer (FIGO IB3–IIA2) and limited nodal disease, with no prior anticancer therapy and good performance status. The trial aims to determine safety and preliminary efficacy in the neoadjuvant setting, informed by prior data on chemoimmunotherapy in locally advanced disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jihong Liu, Ph.D.
• Email: liujih@sysucc.org.cn
• Phone: +86 20 87341779

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.