Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for phase_2

Timeline

4mo left

Started Mar 2023

Typical duration for phase_2

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

Study Progress91%

Mar 2023Sep 2026

First Submitted

Initial submission to the registry

January 31, 2023

Completed

9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed

20 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected

Last Updated

February 9, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

January 31, 2023

Last Update Submit

January 31, 2023

Conditions

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

Outcome Measures

Primary Outcomes (2)

Metachronous liver metastasis rate
The Metachronous liver metastasis rate is the proportion of CTC-positive patients with metachronous liver metastases after conventional therapy or quintuple method intervention.
Up to approximately 3 years
Overall Survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time.
Up to approximately 3 years

Study Arms (2)

Conventional treatment group

EXPERIMENTAL

Conventional treatment was performed according to the NCCN Guidelines for Colorectal Cancer 2023 Edition

Drug: OxaliplatinDrug: Capecitabine

Quintuple method treatment group

EXPERIMENTAL

SOX regimen chemotherapy, low dose cetuximab targeted therapy, and folic acid, vitamin A, metronidazole three-drug regimen were combined. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 \* patient's body surface area, d2-d15 was taken orally by S1, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 \* patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. These regimens last for 6 to 8 sessions.

Drug: OxaliplatinDrug: S1Drug: CetuximabDrug: MetronidazoleDrug: Vitamin ADrug: Folic acid

Interventions

OxaliplatinDRUG

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

Conventional treatment groupQuintuple method treatment group

S1DRUG

Orally on d2-d15 at 20 mg three times daily