Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial
Study Details
Study Description
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 refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 122 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Study group The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel. |
Drug: Anti-PD-1 antibody camrelizumab
Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months
Drug: Albumin-bound paclitaxel
Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses
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Outcome Measures
Primary Outcome Measures
- Overall response rate [One year]
The rates of complete and partial remission
Secondary Outcome Measures
- Progression-free survival [One year]
The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse
- Overall survival [One year]
The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive
- Disease control rate [One year]
The rates of complete and partial remission, and stable disease
- Adverse event rates [One year]
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female of 18-75 years old
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Eastern Cooperative Oncology Group score 0-1
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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
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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
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At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
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Anticipative survival period of 3 months or more
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Lab testing within reference ranges
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With appropriate contraception
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Provided consents of participating the trial
Exclusion Criteria:
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With brain metastasis
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With addiction to psychiatric medications or with mental disorders
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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
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With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment
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With infective disease which need systematic treatment within 14 days
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With severe open trauma, fracture or major surgery with past 4 weeks
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With potential allergy or intolerance to study regimens
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Not eligible for the study judged by researchers
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Lei Li | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Lei Li
Investigators
- Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REPACC-3