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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04558684
Study type Interventional
Source Wuhan Union Hospital, China
Contact
Status Suspended
Phase Phase 1/Phase 2
Start date November 1, 2019
Completion date December 30, 2023

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