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

January 31, 2023 updated by: Liaoning Tumor Hospital & Institute
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with colorectal cancer, clinical stage I to III, underwent radical surgery, and prehepatic CTC≥1 were enrolled. Patients were randomly divided into Conventional treatment group and Quintuple method treatment group. Patients in the Conventional treatment group received conventional treatment according to the NCCN Guidelines for Colorectal Cancer 2023 edition. For patients in the Quintuple method treatment group, Quintuple method intervention was adopted, that is, combined with SOX regimen chemotherapy, low-dose cetuximab targeted therapy and three-drug regimen of folic acid, vitamin A and metronidazole. 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 Digio, 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. The above regimen lasted for 6 to 8 sessions, and enrolled patients were reviewed every 3 months for colorectal cancer-related tumor markers, including MRI and CT imaging. The primary endpoint was radiographically confirmed metachronous liver metastases, and the secondary endpoint was death, observed for 3 years.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages 18-80 at the time of signing the informed consent;
  2. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
  3. Radical surgery has been performed;
  4. Imaging examination showed no liver metastasis;
  5. Prehepatic CTC number ≥1;
  6. The ECOG performance status is 0-1.
  7. No combination of other life-threatening diseases;
  8. Willingness and ability to follow scheduled visits, treatment plans, laboratory tests and other research procedures.

Exclusion Criteria:

  1. Patients with non-primary colorectal cancer;
  2. Patients with liver metastasis or other organ metastasis;
  3. Patients without prehepatic CTC or whose prehepatic CTC were negative;
  4. People who are severely allergic to one or more of the drugs required in the test;
  5. Patients with severe underlying diseases of respiratory, circulatory, urinary and hematopoietic systems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Conventional treatment group
Conventional treatment was performed according to the NCCN Guidelines for Colorectal Cancer 2023 Edition
Drug: Oxaliplatin
Oxaliplatin via intravenous drip on d1 at a dose of 130mg/m2 × patient 's body surface area
Drug: Capecitabine
Capecitabine via orally on d2-d15 two times daily at a dose of 1000mg/m2 × patient 's body surface area.
EXPERIMENTAL: Quintuple method treatment group
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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metachronous liver metastasis rate
Time Frame: Up to approximately 3 years
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)
Time Frame: Up to approximately 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaoning Tumor Hospital & Institute

Investigators

  • Study Director: Zhang Zhongguo, Doctor, Liaoning Tumor Hospital & Institute Shenyang, Liaoning, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2023

Primary Completion (ANTICIPATED)

March 1, 2026

Study Completion (ANTICIPATED)

September 1, 2026

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230201zzg

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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