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

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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorLiaoning Cancer Hospital & Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 18-80 at the time of signing the informed consent;

Histologically or cytologically confirmed adenocarcinoma of the colon or rectum;

Radical surgery has been performed;

Imaging examination showed no liver metastasis;

Disqualifiers

Patients with non-primary colorectal cancer;

Patients with liver metastasis or other organ metastasis;

Patients without prehepatic CTC or whose prehepatic CTC were negative;

People who are severely allergic to one or more of the drugs required in the test;

Trial design

Design model

Single group

Treatments tested in this trial

Oxaliplatin
Drug
Oxaliplatin via intravenous drip on d1 at a dose of 130mg/m2 × patient 's body surface area
S1
Drug
Orally on d2-d15 at 20 mg three times daily
Cetuximab
Drug
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.
Metronidazole
Drug
Metronidazole 0.4g/time, qd
Vitamin A
Drug
Vitamin A 25,000 units/time, qd
Folic acid
Drug
Folic acid 0.4 mg/time, qd
Capecitabine
Drug
Capecitabine via orally on d2-d15 two times daily at a dose of 1000mg/m2 × patient 's body surface area.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Conventional treatment groupExperimental treatment 2 interventions

Group B: Quintuple method treatment groupExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

Up to approximately 3 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liaoning Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: