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Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Primary Purpose

Colorectal Cancer, Liver Metastases, Circulating Tumor Cell

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Colorectal resection surgery.
FOLFOX chemotherapy regimen
Capecitabine
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Liver Metastases, ctDNA, maintenance therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both males and females, aged 18-75 years; Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect); Postoperative ctDNA-positive patients; ASA grade < IV and/or ECOG performance status score ≤ 2; Participants must have a full understanding of the study and voluntarily sign an informed consent form. Exclusion Criteria: Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc. Patients with a history of other malignant tumors. Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy. Patients who are allergic to any component of the study. Patients who have received other tumor-related investigational drug treatments. Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases. Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities. Patients with a history of severe mental illness. Pregnant or lactating women. Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

Sites / Locations

  • The Sixth Affiliate Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Adjuvant chemotherapy combined with maintenance therapy

Single adjuvant chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

3-years Progression Free Survival
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
5-years Progression Free Survival
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.

Secondary Outcome Measures

3-years overall survival
Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
5-years overall survival
Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
Complication
he complications of adjuvant therapy usually refer to the adverse events that occur during or after treatment, including but not limited to chemotherapy-related adverse reactions, radiation therapy-related adverse reactions, and postoperative complications. Specifically, chemotherapy-related adverse reactions may include nausea, vomiting, diarrhea, anemia, and infections; radiation therapy-related adverse reactions may include skin inflammation, nausea, vomiting, diarrhea, fatigue, and dry mouth; postoperative complications may include bleeding, infection, intestinal obstruction, and poor wound healing. Researchers typically record the types, severity, and impact of these complications on treatment to evaluate the safety and tolerability of adjuvant therapy.

Full Information

First Posted
March 20, 2023
Last Updated
April 3, 2023
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05797077
Brief Title
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA
Official Title
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
February 20, 2029 (Anticipated)
Study Completion Date
February 20, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastases, Circulating Tumor Cell, Cancer, Therapy-Related
Keywords
Colorectal Cancer, Liver Metastases, ctDNA, maintenance therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
346 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant chemotherapy combined with maintenance therapy
Arm Type
Experimental
Arm Title
Single adjuvant chemotherapy
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Colorectal resection surgery.
Intervention Description
Colorectal cancer radical resection combined with liver metastasis resection or ablation.
Intervention Type
Drug
Intervention Name(s)
FOLFOX chemotherapy regimen
Other Intervention Name(s)
CapeOx chemotherapy regimen
Intervention Description
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
5-FU/LV
Intervention Description
Maintenance therapy is recommended to be continued with low-toxicity drugs such as 5-FU/LV or capecitabine, and may be combined with targeted therapy. Treatment should be discontinued once ctDNA testing is negative.
Primary Outcome Measure Information:
Title
3-years Progression Free Survival
Description
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Time Frame
3 years after operation.
Title
5-years Progression Free Survival
Description
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
Time Frame
5 years after operation.
Secondary Outcome Measure Information:
Title
3-years overall survival
Description
Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
Time Frame
3 years after operation.
Title
5-years overall survival
Description
Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.
Time Frame
5 years after operation.
Title
Complication
Description
he complications of adjuvant therapy usually refer to the adverse events that occur during or after treatment, including but not limited to chemotherapy-related adverse reactions, radiation therapy-related adverse reactions, and postoperative complications. Specifically, chemotherapy-related adverse reactions may include nausea, vomiting, diarrhea, anemia, and infections; radiation therapy-related adverse reactions may include skin inflammation, nausea, vomiting, diarrhea, fatigue, and dry mouth; postoperative complications may include bleeding, infection, intestinal obstruction, and poor wound healing. Researchers typically record the types, severity, and impact of these complications on treatment to evaluate the safety and tolerability of adjuvant therapy.
Time Frame
5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both males and females, aged 18-75 years; Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect); Postoperative ctDNA-positive patients; ASA grade < IV and/or ECOG performance status score ≤ 2; Participants must have a full understanding of the study and voluntarily sign an informed consent form. Exclusion Criteria: Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc. Patients with a history of other malignant tumors. Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy. Patients who are allergic to any component of the study. Patients who have received other tumor-related investigational drug treatments. Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases. Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities. Patients with a history of severe mental illness. Pregnant or lactating women. Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.
Facility Information:
Facility Name
The Sixth Affiliate Hospital of Sun Yat-Sen University
City
GuangZhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxin Luo, PhD,MD
Phone
86-13826190263
Email
luoyx25@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yaoyi Huang, BS
Phone
86-15986423743
Email
huangyy355@mail2.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

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