NCT04854668

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

A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 748 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride capsule	Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)；
DRUG	Bevacizumab	Bevacizumab 7.5mg/kg, intravenous drip, on Day 1
DRUG	Oxaliplatin	Oxaliplatin 130mg/m2, intravenous drip, on Day 1；
DRUG	Capecitabine	Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.

Timeline

• Start date: 2021-05-27
• Primary completion: 2024-12-31
• Completion: 2026-12-01
• First posted: 2021-04-22
• Last updated: 2026-01-30

Locations

92 sites across 1 country: China