Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07491159
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

Colorectal cancer (CRC) is the fourth leading cause of cancer death worldwide, claiming approximately 900,000 lives annually. In China, CRC has become one of the top three most common cancers, with about 555,000 new cases and 286,000 deaths reported in 2020. For patients with advanced metastatic colorectal cancer (mCRC), chemotherapy remains the main treatment approach. While first and second-line treatments have improved survival rates, treatment options become very limited after these initial therapies fail. Current third-line options include single-drug treatments with fruquintinib, regorafenib, or Trifluridine/Tipiracil(TAS-102). Although these medications can extend survival, their effectiveness still needs improvement. Additionally, approximately 95% of mCRC patients have a tumor type \[Proficient Mismatch Repair(pMMR)/Microsatellite Stable(MSS)\] that responds poorly to immunotherapy alone, making it crucial to find ways to expand the benefits of immunotherapy to more patients. This study aims to evaluate the effectiveness and safety of combining: Fruquintinib (a targeted therapy) Immune checkpoint inhibitors (immunotherapy) TAS-102 (oral chemotherapy)in patients with unresectable metastatic colorectal cancer who have failed standard second-line treatments. By exploring combination therapy strategies, this research hopes to improve treatment response rates, extend overall survival and provide new treatment options for patients with limited choices

Key Dates

First listed
Mar 24, 2026
Start date
Jul 1, 2023
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
106 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil
    Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil
  • Experimental: Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab
    Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab

Primary Outcome Measure

RP2D [ Time Frame: From enrollment to the end of treatment at 4 week ]

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