NCT03645876

SHR-1210 in Combination With BP102 and XELOX in Patient With Metastatic Colorectal Cancer

SHR-1210，a Novel Anti-pd-1 Antibody, in Combination With BP102,a Biosimilar of Bevacizumab, and XELOX, (Oxaliplatin Plus Capecitabine) in Patient With Metastatic Colorectal Cancer: a Single-arm, Open Label, Multi-center, Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single-arm, multi-center, phase II study of SHR-1210 in metastatic colorectal cancer patients with the recurrent lesion(s) post-surgery or the untreated mCRC. SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1).BP102 is a humanized recombinant monoclonal IgG1 antibody. The primary objective of this study is to investigate the safety and efficacy of the subjects who given the combination therapy.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SHR-1210	200mg
DRUG	BP102	7.5mg/kg
DRUG	oxaliplatin	130mg/m2
DRUG	capecitabine	1000mg/m2

Timeline

• Start date: 2018-11-08
• Primary completion: 2019-04-18
• Completion: 2019-04-18
• First posted: 2018-08-24
• Last updated: 2019-05-10

Locations

1 site across 1 country: China