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Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection

NCT05720559 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-09

No results posted yet for this study

Summary

In this study, the Quintuple method was applied for early intervention of prehepatic CTC-positive bowel cancer patients without dominant liver metastasis, aiming to explore the blocking effect of the Quintuple method on the metachronous liver metastases of colorectal cancer. A one-arm randomized clinical trial was conducted, and the patients were grouped according to their treatment methods. The patients with metachronous liver metastases were used as the end point of the experiment to evaluate the blocking effect of quintuple therapy.

Conditions

  • Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal Cancer

Interventions

DRUG

Oxaliplatin

Oxaliplatin via intravenous drip on d1 at a dose of 130mg/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 25,000 units/time, qd

DRUG

Folic acid

Folic acid 0.4 mg/time, qd

DRUG

Capecitabine

Capecitabine via orally on d2-d15 two times daily at a dose of 1000mg/m2 × patient 's body surface area.

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Zhang Zhongguo, Doctor · Liaoning Tumor Hospital & Institute Shenyang, Liaoning, China

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
2023-03-01
Primary Completion
2026-03-01
Completion
2026-09-01

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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 NCT05720559 on ClinicalTrials.gov