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

NCT ID: NCT05797077

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2031-02-20

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.

Conditions

Colorectal Cancer; Liver Metastases; Circulating Tumor Cell; Cancer, Therapy-Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant chemotherapy combined with maintenance therapy

Group Type: EXPERIMENTAL

Colorectal resection surgery.

Intervention Type: PROCEDURE

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

FOLFOX chemotherapy regimen

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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.

Single adjuvant chemotherapy

Group Type: SHAM_COMPARATOR

Colorectal resection surgery.

Intervention Type: PROCEDURE

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

FOLFOX chemotherapy regimen

Intervention Type: DRUG

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

Interventions

Colorectal resection surgery.

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

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

CapeOx chemotherapy regimen; 5-FU/LV

Eligibility Criteria

Inclusion Criteria

1. Both males and females, aged 18-75 years;

2. 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);

3. Postoperative ctDNA-positive patients;

4. ASA grade < IV and/or ECOG performance status score ≤ 2;

5. Participants must have a full understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria

1. Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.

2. Patients with a history of other malignant tumors.

3. Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.

4. Patients who are allergic to any component of the study.

5. Patients who have received other tumor-related investigational drug treatments.

6. Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.

7. 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.

8. Patients with a history of severe mental illness.

9. Pregnant or lactating women.

10. Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanxin Luo,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yanxin Luo, PhD,MD

Role: primary

luoyx25@mail.sysu.edu.cn

86-13826190263

Yaoyi Huang, BS

Role: backup

huangyy355@mail2.sysu.edu.cn

86-15986423743

Other Identifiers

1010(PY)2022-10

Identifier Type: -

Identifier Source: org_study_id