Status:
NOT_YET_RECRUITING
QL706 + Chemo ± Bevacizumab in Anti-PD-(L)1-Resistant R/M Cervical Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Recurrent Cervical Cancer
Metastatic Cervical Cancer
Eligibility:
FEMALE
18-75 years
Brief Summary
This is a clinical research study for women with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1/PD-L1 inhibitor immunotherapy. The study will e...
Detailed Description
This is a prospective, open-label, single-arm, single-center phase II clinical trial investigating the efficacy and safety of a combination therapy in patients with recurrent or metastatic cervical ca...
Eligibility Criteria
Inclusion
- Female patients aged 18 to 75 years.
- Histologically, pathologically, or radiologically confirmed recurrent or metastatic cervical cancer.
- At least one measurable lesion as defined by RECIST 1.1 (non-nodal lesion longest diameter ≥10 mm or lymph node short axis ≥15 mm).
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Disease progression after receiving at least one prior anti-PD-1/PD-L1 monoclonal antibody therapy (alone or in combination).
- Adequate organ function within 14 days before enrollment:
- Absolute neutrophil count (ANC) \>1.5 × 10⁹/L Platelets \>100 × 10⁹/L Hemoglobin \>100 g/L Serum total bilirubin \<1.5 × ULN ALT and AST \<3 × ULN Creatinine clearance (CCr) \>60 mL/min
- Voluntarily sign the informed consent form, able to understand and comply with study requirements.
Exclusion
- Known allergy to any component of the study drugs.
- Prior treatment with any CTLA-4 targeting medication.
- Adverse reactions from previous anti-cancer therapy have not recovered to ≤ Grade 1 (per CTCAE v5.0) (except for toxicities without safety risk per investigator's judgment, e.g., alopecia).
- History of other malignancies within the past 5 years, except for cured malignancies.
- Severe comorbid conditions, including but not limited to:
- Extensive interstitial lung disease requiring medication. Active or uncontrolled infections (e.g., tuberculosis, HIV). Decompensated liver disease, active hepatitis, or active bleeding. History of cerebrovascular accident or pulmonary embolism. Active, known, or suspected autoimmune diseases. Active infection requiring systemic anti-infective therapy.
- Ascites with depth \>5 cm measured by ultrasound or CT, OR ascites causing severe symptoms (e.g., abdominal distension, dyspnea, circulatory dysfunction) significantly impacting physical function or study safety.
- Pregnant, planning pregnancy, or lactating women.
- Any other condition deemed by the investigator as unsuitable for participation in this study.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07186868
Start Date
October 15 2025
End Date
December 30 2027
Last Update
September 22 2025
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