drugset / Trial / NCT05216653

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM)

NCT05216653

Phase 2 Completed 32 enrolled Sir Run Run Shaw Hospital
NaSingle-groupOpen-labelTreatment

Summary

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer. According to the existing theory, the use of PD-L1 monoclonal antibody after short-course radiotherapy may be the best solution. In this study, the investigators will perform single-cell sequencing of participants tissue samples, fully explore the multi-dimensional omics information of tumors and microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

Timeline

Start
2022-04-07
Primary completion
2023-03-31
Completion
2025-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Envafolimab Monoclonal antibody 150 mg Subcutaneous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications