NCT04231552

Preoperative Short Course Radiotherapy With Chemotherapy and Camerelizumab in Locally Advanced Rectal Cancer

Preoperative Short Course Radiotherapy With Consolidation Chemotherapies and Camrelizumab Followed by Delayed Surgery in Locally Advanced Rectal Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a open-label, single-arm study to investigate the safety and efficacy of consolidative chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.

Detailed description

Patients with locally advanced rectal cancer (cT3-4 or N+) are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with consolidation chemotherapy consisting two cycles of CAPOX chemotherapy and camrelizumab, an anti-PD-1 antibody drug for two cycles. Subsequent surgical therapy is performed to evaluate the safety and efficacy.

Conditions

• Rectal Cancer
• Radiotherapy
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Camrelizumab	Radiotherapy with CAPOX+ Camrelizumab following surgical therapy Radiation: 25 Gy/5 fractions CAPOX (2 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine:Dose of 2000mg/m2,14days, q3w Camrelizumab (2 cycles): 200mg on day 1 of each cycle, q3w Surgical therapy: the resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)

Timeline

• Start date: 2019-11-10
• Primary completion: 2020-09-30
• Completion: 2023-09-30
• First posted: 2020-01-18
• Last updated: 2020-11-30

Locations

1 site across 1 country: China