Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy
Status:
Recruiting
Trial end date:
2021-06-06
Target enrollment:
Participant gender:
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.