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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT04854668
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib hydrochloride capsule — DRUG
    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)；
  • Bevacizumab — DRUG
    Bevacizumab 7.5mg/kg, intravenous drip, on Day 1
  • Oxaliplatin — DRUG
    Oxaliplatin 130mg/m2, intravenous drip, on Day 1；
  • Capecitabine — DRUG
    Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.

Study Details

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.

Key Dates

First listed
Apr 22, 2021
Start date
May 27, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
748 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anlotinib + CapeOx
    Anlotinib combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Anlotinib combined with Capecitabine.
  • Active Comparator: Bevacizumab + CapeOx
    Bevacizumab combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Bevacizumab combined with Capecitabine.

Primary Outcome Measure

Progression Free Survival (PFS) assessed by IRC [ Time Frame: Baseline up to 15 months ]

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