Status:
UNKNOWN
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial
Lead Sponsor:
Lei Li
Conditions:
Recurrent Cervical Carcinoma
Persistent Advanced Cervical Carcinoma
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This is a updated trial of NCT04188860 as a multi-center study. For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were ...
Eligibility Criteria
Inclusion
- Female of 18-75 years old
- Eastern Cooperative Oncology Group score 0-1
- Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
- Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen
- At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
- Anticipative survival period of 3 months or more
- Lab testing within reference ranges
- With appropriate contraception
- Provided consents of participating the trial
Exclusion
- With brain metastasis
- With addiction to psychiatric medications or with mental disorders
- With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of \> 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency
- With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment
- With infective disease which need systematic treatment within 14 days
- With severe open trauma, fracture or major surgery with past 4 weeks
- With potential allergy or intolerance to study regimens
- Not eligible for the study judged by researchers
Key Trial Info
Start Date :
March 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 13 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05290935
Start Date
March 13 2022
End Date
March 13 2024
Last Update
March 22 2022
Active Locations (1)
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1
Lei Li
Beijing, Beijing Municipality, China, 100730