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Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases

NCT05774964 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-20

No results posted yet for this study

Summary

The aim of this study is to explore the therapeutic effect of Quintuple method in the treatment of patients with multiple and refractory liver metastases from colorectal cancer. A randomized single-arm clinical trial was conducted.The intervention group was treated with single SOX chemotherapy, SOX chemotherapy combined with cetuximab targeted therapy, SOX chemotherapy combined with low-dose cetuximab targeted therapy combined with three-drug regimen（Quintuple method）, and the RECIST 1.1 solid tumor evaluation criteria were used to assess the disease.

Conditions

  • For Patients With Colorectal Cancer Liver Metastases Who Were Not Able to Curative Surgical Resection.Focused on the Treatment Effect With the Quintuple Method

Interventions

DRUG

Oxaliplatin

Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area

DRUG

S1

Orally on d2-d15 at 20 mg three times daily

DRUG

Cetuximab

Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.

DRUG

Metronidazole

Metronidazole 0.4g/time, qd

DRUG

Vitamin A

Vitamin A 5,000 units/time, qd

DRUG

Folic acid

Folic acid 5 mg/time, qd

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2025-03-15
Completion
2025-03-15

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 NCT05774964 on ClinicalTrials.gov