drugset / Trial / NCT04188860

Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

NCT04188860 ↗

Phase 2 Completed 34 enrolled Lei Li
NaSingle-groupOpen-labelTreatment

Summary

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 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest 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
2019-12-06
Primary completion
2022-01-06
Completion
2022-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg —
Subject Paclitaxel Small molecule 200 mg —
Subject Paclitaxel Small molecule 300 mg —

Indications