Fruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer

Sponsor
Liu Huang
Study ID
NCT07051785
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer (CRC)

Eligibility Criteria

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

Interventions

  • Fruquintinib+Irinotecan Liposome+Capecitabine — DRUG
    Stage 1: Participants received fruquintinib, irinotecan liposome, and capecitabine for 6-8 cycles. If no disease progression was observed after the initial treatment, patients were transitioned to maintenance therapy with fruquintinib and capecitabine. Stage 2: if the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage. Participants were randomly assigned to two groups (A and B), Group A: Fruquintinib + irinotecan liposome + capecitabine. After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy with Fruquintinib + capecitabine
  • Bevacizumab+Irinotecan Liposome+Capecitabine — DRUG
    Stage 2: if the primary endpoint of progression-free survival (PFS) was met in the first stage, participants were eligible for the second stage. Participants were randomly assigned to two groups (A and B), Group B: Bevacizumab + irinotecan liposome + capecitabine. After 6-8 cycles of treatment, patients who had no disease progression were transitioned to maintenance therapy with bevacizumab + capecitabine

Study Details

This study is divided into two phases. The first phase aims to preliminarily evaluate the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine as second-line therapy for advanced metastatic colorectal cancer. The second phase is designed to further assess the efficacy and safety of fruquintinib in combination with irinotecan liposome and capecitabine compared to bevacizumab in combination with chemotherapy, also as second-line treatment for advanced metastatic colorectal cancer. The first phase is a single-arm study, while the second phase is a randomized (1:1) controlled trial. Entry into the second phase is determined by the investigators based on the efficacy results from the first phase study: if the primary endpoint of progression-free survival (PFS) is met in the first phase, participants will proceed to the second phase study. In the second phase, randomization is stratified according to the RAS status and the presence of disease progression within six months of adjuvant or neoadjuvant therapy. In the second phase, patients will be ramdomly assigned to receive fruquintinib(4mg/d, PO, D1-14, Q3W) in combination with irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) and capecitabine(800mg/m2, PO, BID, D1-14, Q3W) or bevacizumab(7.5mg/kg, ivgtt, D1, Q3W) in combination with the same chemotherapy. Every three weeks is a cycle.

Key Dates

Start date
Jul 7, 2025
Status verified
Jun 2025
Primary completion
Jul 6, 2027
Completion
Jul 6, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fruquintinib+Irinotecan Liposome+Capecitabine
    fruquintinib(4mg/d, PO, D1-14, Q3W) + irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) + capecitabine(800mg/m2, PO, BID, D1-14, Q3W), every three weeks is a cycle.
  • Active Comparator: Bevacizumab+Irinotecan Liposome+Capecitabine
    bevacizumab(7.5mg/kg, ivgtt, D1, Q3W)+irinotecan liposome(56mg/m2, ivgtt, D1, Q3W) + capecitabine(800mg/m2, PO, BID, D1-14, Q3W), every three weeks is a cycle.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: one year ]

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