Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases

March 7, 2023 updated by: Liaoning Tumor Hospital & Institute

A Prospective, Single-arm, Single-center, Phase II Clinical Trial to Evaluate the Efficacy of Quintuple Method for the Treatment of Multiple Refractory Colorectal Liver Metastases

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with inoperable colorectal liver metastases were selected for genetic testing and enrolled if Kras/Nras/Braf wild-type was detected. The enrolled patients were randomly divided into three groups, in which patients in the single chemotherapy group were treated with SOX regimen alone for chemotherapy;patients in the chemotherapy targeted group were treated with SOX regimen chemotherapy combined with cetuximab targeted therapy; patients in the Quintuple method group were treated with SOX regimen chemotherapy,cetuximab targeted therapy and folic acid, vitamin A, and metronidazole three-drug regimen. Specific drugs were administered at the following doses: SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and S1 orally on d2-d15 at 20 mg three times daily. 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 0.4 g/time, qd; vitamin A 5,000 units/time, qd; folic acid 5 mg/time, qd. The latter three drugs were continued until the end of all chemotherapy cycles.Tumor markers associated with liver metastases from colorectal cancer,including magnetic resonance imaging and computed tomography, wererepeated every 3 months and disease was assessed using RECIST 1.1 criteria for the evaluation of solid tumors. The primary end point was death, and the secondary end point was disease progression.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Tumor Hospital & Institute

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. Aged 18-80 years at the time of signing the informed consent form;
  2. Patients with histologically or cytologically confirmed adenocarcinoma of the colon or rectum (stage IV);
  3. Patients with liver metastases found by imaging examination, and liver metastases cannot be radically resected, Or relapse liver metastasis;
  4. At least one measurable metastatic lesion as defined by RECIST version 1.1;
  5. Genetic test results are Kras/Nras/Braf wild-type or mutation type;
  6. ECOG performance status 0-1;
  7. Except for the liver, other organs function well;
  8. Willingness and ability to comply with scheduled visits, treatment plans,laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Patients with non-primary intestinal cancer;
  2. Patients whose primary tumor as well as metastases can be radically resected by surgery;
  3. One or several serious allergies to each drug required for the trial;
  4. Combined with respiratory, circulatory, urinary, hematopoietic and other serious underlying diseases.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy alone group
Patients treated with chemotherapy using SOX regimen alone. SOX regimen every 3 weeks,oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily.
Drug: S1
Orally on d2-d15 at 20 mg three times daily
Other Names:
  • Tegafur,Gimeracil and Oteracil Porassium Capsules
Drug: Oxaliplatin
Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area
Experimental: Chemotherapy targeted group
Patients treated with cetuximab targeted therapy in combination with chemotherapy using SOX regimen.SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily. 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: S1
Orally on d2-d15 at 20 mg three times daily
Other Names:
  • Tegafur,Gimeracil and Oteracil Porassium Capsules
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: Oxaliplatin
Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area
Experimental: Quintuple method group
Patients treated with a combination of SOX regimen, cetuximab, and folic acid, vitamin A, and metronidazole three-drug regimen.SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily. 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 0.4g/time, qd;vitamin A 5,000 units/time, qd; folic acid 5 mg/time,qd. The latter three drugs were continued until the end of all chemotherapy cycles.
Drug: S1
Orally on d2-d15 at 20 mg three times daily
Other Names:
  • Tegafur,Gimeracil and Oteracil Porassium Capsules
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: Oxaliplatin
Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area
Drug: Vitamin A
Vitamin A 5,000 units/time, qd
Drug: Folic acid
Folic acid 5 mg/time, qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to approximately 2 years
Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1
Up to approximately 2 years
Overall Survival (OS)
Time Frame: Up to approximately 2 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 2 years
Progression Free Survival (PFS)
Time Frame: Up to approximately 2 years
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause.
Up to approximately 2 years

Collaborators and Investigators

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

Sponsor

Liaoning Tumor Hospital & Institute

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 15, 2023

Primary Completion (Anticipated)

March 15, 2025

Study Completion (Anticipated)

March 15, 2025

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230303zzg

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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