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

NCT05435313 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-01-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

HAIC

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.

DRUG

Fruquintinib

3mg, qd, po, 21 days for a cycle, Suspend medication on the day of HAIC

DRUG

Tislelizumab

200mg, ivgtt, d1, 21 days for a cycle

DRUG

Raltitrexed

2 mg/m2, hepatic artery infusion for 15 min, d1, 4-6 Cycles

DRUG

Oxaliplatin

85 mg/m2, hepatic artery infusion for 2 h, d1, 4-6 Cycles

DRUG

Irinotecan

120mg/m2, hepatic artery perfusion for 30-90min, d1, 4-6 Cycles

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2024-01-31
Completion
2024-02-29

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435313 on ClinicalTrials.gov