Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）

Phase 2 Not yet recruiting 50 enrolled JIN JING

Non-randomizedSequentialOpen-labelTreatment

Summary

This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with AK104 and chemotherapy + TME surgery in patients with advanced rectal cancer.

Timeline

Start: 2023-04-24
Primary completion: 2027-04-24
Completion: 2027-04-24

Publications

Xu T, Feng L, Zhang W, Li H, Ma H, Abulimiti M, Tan Y, Deng F, Huang W, Zou S, Kang W, Jiang L, Wang Y, Hu C, Chen Y, Zhou H, Tang Y, Jin J. The efficacy and safety of short-course radiotherapy followed by sequential chemotherapy and Cadonilimab for locally advanced rectal cancer: a protocol of a phase II study. BMC Cancer. 2024 Apr 19;24(1):501. doi: 10.1186/s12885-024-12254-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cadonilimab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

Indications

No indication recorded.