NCT05290935

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

Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Multi-Center, Open, Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Cervical Carcinoma
• Persistent Advanced Cervical Carcinoma
• Chemotherapy
• Immune Checkpoint Inhibitors
• Anti-PD-1 Antibody
• Albumin-bound Paclitaxel

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-13
• Primary completion: 2022-12-13
• Completion: 2024-03-13
• First posted: 2022-03-22
• Last updated: 2022-03-22

Locations

1 site across 1 country: China