NCT04636008

Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer

The Safety and Efficacy of Sintilimab Combined With Hypofractionated Radiotherapy in MSI-H/dMMR Rectal Cancer: a Prospective, Single-arm, Multicenter, Phase Ib Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)/ DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.

Detailed description

The patients meet the inclusion criteria. After signing the informed consent, they are given radiotherapy 5Gyx5 and sintilimab 200mg ivgtt D1, D15, D29. Radical surgery is performed 6-8 weeks after radiotherapy.

Conditions

• Anti-PD-1 Antibody
• Radiotherapy
• Rectal Cancer
• MSI-H
• Mmr Deficiency

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab+Hypofractionated radiotherapy
RADIATION	Hypofractionated Radiotherapy	Hypofractionated Radiotherapy

Timeline

• Start date: 2020-08-14
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-11-19
• Last updated: 2024-08-06

Locations

1 site across 1 country: China