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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05797077

Collaborator

(none)

346

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Liver Metastases Circulating Tumor Cell Cancer, Therapy-Related	Procedure: Colorectal resection surgery. Drug: FOLFOX chemotherapy regimen Drug: Capecitabine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

346 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.

Actual Study Start Date :

Feb 20, 2023

Anticipated Primary Completion Date :

Feb 20, 2029

Anticipated Study Completion Date :

Feb 20, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adjuvant chemotherapy combined with maintenance therapy	Procedure: Colorectal resection surgery. Colorectal cancer radical resection combined with liver metastasis resection or ablation. Drug: FOLFOX chemotherapy regimen Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy. Other Names: CapeOx chemotherapy regimen Drug: Capecitabine 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. Other Names: 5-FU/LV
Sham Comparator: Single adjuvant chemotherapy	Procedure: Colorectal resection surgery. Colorectal cancer radical resection combined with liver metastasis resection or ablation. Drug: FOLFOX chemotherapy regimen Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy. Other Names: CapeOx chemotherapy regimen

Arm

Intervention/Treatment

Experimental: Adjuvant chemotherapy combined with maintenance therapy

Procedure: Colorectal resection surgery.

Colorectal cancer radical resection combined with liver metastasis resection or ablation.

Drug: FOLFOX chemotherapy regimen

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

Other Names:

CapeOx chemotherapy regimen

Drug: Capecitabine

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.

Other Names:

5-FU/LV

Sham Comparator: Single adjuvant chemotherapy

Procedure: Colorectal resection surgery.

Colorectal cancer radical resection combined with liver metastasis resection or ablation.

Drug: FOLFOX chemotherapy regimen

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

Other Names:

CapeOx chemotherapy regimen

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.