NCT05311566

PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer

Effectiveness and Safety of Camrelizumab Combined With Concurrent Chemoradiotherapy for FIGO IB2-IIIB Cervical Cancer: A Single-center, Single-arm, Open-phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, single-arm, open-phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB cervical cancer. Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks, camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other reasons specified in the protocol. Subjects who finished treatment entered the safety follow-up or survival follow-up.

Conditions

• Cervical Carcinoma
• Chemoradiotherapy
• Anti-programmed Cell Death Receptor 1
• Immunotherapy
• Immune Checkpoint Inhibitor
• Survival Outcomes
• Adverse Events
• Early Stage Cervical Cancer
• Locally Advanced Cervical Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Camrelizumab plus Concurrent chemoradiotherapy	Participants will be given intravenous administration of Camrelizumab (200mg，every 2 weeks),Cisplatin(40mg/m²，everyweek) and Radiotherapy. After completing 6\~8weeks of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until disease progression or unacceptable toxicity.

Timeline

• Start date: 2022-03-27
• Primary completion: 2023-03-27
• Completion: 2026-03-27
• First posted: 2022-04-05
• Last updated: 2022-04-13

Locations

1 site across 1 country: China