drugset / Trial / NCT04854668

A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer

NCT04854668

Phase 3 Active not recruiting 748 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open label, randomized, phase Ⅲ study to treat subjects with RAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into two arms consist of Anlotinib (3 weeks/cycle) + CapeOx and Bevacizumab (3 week/cycle) + CapeOx at a ratio of 1:1. This study is conducted to assess the efficacy and safety of Anlotinib and Chemotherapy as first-line treatment in subjects with RAS/BRAF wild-type Metastatic Colorectal Cancer.

Timeline

Start
2021-05-27
Primary completion
2024-12-31
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Catequentinib Small molecule 12 mg Oral
Background Capecitabine Small molecule 850 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications