Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial

• Status: Recruiting
• Trial end date: 2024-03-13
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lei Li
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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