NCT04188860

Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

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, Single Center, Open, Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Cervical Carcinoma
• Persistent Advanced Cervical Carcinoma
• Chemotherapy
• Anti-PD-1 Antibody
• Immunotherapy

Interventions

Type	Name	Description
DRUG	A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel	A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients: * 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 * Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

Timeline

• Start date: 2019-12-06
• Primary completion: 2022-01-06
• Completion: 2022-03-06
• First posted: 2019-12-06
• Last updated: 2022-03-15

Locations

1 site across 1 country: China