NCT05068206

A Clinical Study to Compare the Efficacy and Safety of AK105 Plus Anlotinib and Capecitabine/Oxaliplatin (CapeOx) , Anlotinib Plus CapeOx, Bevacizumab Plus CapeOx

A Multi-center, Randomized, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AK105 Plus Anlotinib and CapeOx, Anlotinib in Combination With CapeOx Versus Bevacizumab in Combination With CapeOx in the Fisrt-line Treatment of Unresectable Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A clinical study to compare the efficacy and safety of AK105 plus anlotinib and Capecitabine/Oxaliplatin (CapeOx) , anlotinib plus CapeOx, bevacizumab plus CapeOx. A total of 120 cases will be enrolled to the group.

Conditions

• Unresectable Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	AK105 injection	AK105 is programmed death 1（PD-1） monoclonal antibody
DRUG	Anlotinib hydrochloride capsule	Anlotinib is small molecule multi-target tyrosine kinase inhibitor.
DRUG	CapeOX	CapeOX is Capecitabine+Oxaliplatin. Capecitabine is a kind of fluorouracil drug, and Oxaliplatin is a kind of platinum anticancer drug.
DRUG	Bevacizumab	Bevacizumab is a recombinant human monoclonal antibody.

Timeline

• Start date: 2021-10-08
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2021-10-05
• Last updated: 2021-10-20

Locations

13 sites across 1 country: China