Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial
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.
Timeline
- Start
- 2022-03-13
- Primary completion
- 2022-12-13
- Completion
- 2024-03-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | — |
| Subject | Paclitaxel | Small molecule | 200 mg | — |
| Subject | Paclitaxel | Small molecule | 300 mg | — |