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FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients

NCT05727163 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-05-30

No results posted yet for this study

Summary

This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

Dexamethasone

25mg via HAI (Pre-chemotherapy)

DRUG

Anisodamine

10 mg via HAI (Pre-chemotherapy)

DRUG

Oxaliplatin

85 mg/m2 via HAI over 3 hours

DRUG

Leucovorin

200 mg/m2 via HAI

DRUG

Fluorouracil

400 mg/m2 via HAI and 2.4g/m2 via HAI over 48 hours

DRUG

Irinotecan

150 mg/m2 intravenously

DRUG

Bevacizumab

5 mg/kg intravenously

DRUG

Oxaliplatin

85 mg/m2 intravenously over 3 hours

DRUG

Leucovorin

200 mg/m2 intravenously

DRUG

Fluorouracil

400 mg/m2 intravenously + 2400 mg/m2 continuous intravenous infusion over 46 hours

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05727163 on ClinicalTrials.gov