NCT04558684

Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer

Short Course Radiotherapy With Total Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer

• Status: Suspended
• 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 Total neoadjuvant chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy in patients with rectal cancer.

Detailed description

Patients with rectal cancer are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with total neoadjuvant chemotherapy and camrelizumab, an anti-PD-1 antibody drug. The Primary Objective is to assess clinical complete response of an organ preservation approach and the secondary objective to assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach.

Conditions

• Rectal Cancer
• Radiotherapy
• Immunotherapy
• Organ Preservation

Interventions

Type	Name	Description
DRUG	Chemotherapy	CAPOX (6 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine: Dose of 2000mg/m2,14 days, q3w
DRUG	Immunotherapy	Camrelizumab (6 cycles): 200mg on day 1 of each cycle, q3w
RADIATION	IMRT	Radiotherapy (5 Gy x 5 fractions)

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-09-30
• Completion: 2023-12-30
• First posted: 2020-09-22
• Last updated: 2024-01-03

Locations

1 site across 1 country: China