Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Therapy

Sponsor
Fudan University
Study ID
NCT05435313
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • HAIC — PROCEDURE
    After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs.
  • Fruquintinib — DRUG
    3mg, qd, po, 21 days for a cycle, Suspend medication on the day of HAIC
  • Tislelizumab — DRUG
    200mg, ivgtt, d1, 21 days for a cycle
  • Raltitrexed — DRUG
    2 mg/m2, hepatic artery infusion for 15 min, d1, 4-6 Cycles
  • Oxaliplatin — DRUG
    85 mg/m2, hepatic artery infusion for 2 h, d1, 4-6 Cycles
  • Irinotecan — DRUG
    120mg/m2, hepatic artery perfusion for 30-90min, d1, 4-6 Cycles

Study Details

This is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of fruquintinib combined with tislelizumab and HAIC (hepatic arterial infusion chemotherapy) in patients with colorectal liver metastases cancer (CRLM) who failed standard therapy.

Key Dates

Start date
Jul 12, 2022
Status verified
Jan 2024
Primary completion
Jan 31, 2024
Completion
Feb 29, 2024

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combination therapy
    Combination: Fruquintinib plus Tislelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Tislelizumab

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: 24 months ]

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