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

NCT05797077 | Recruiting Phase 3 DMC

• 1 other identifier: 1010(PY)2022-10
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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

Keywords

Colorectal Cancer; Liver Metastases; ctDNA; maintenance therapy

Outcome Measures

Primary Outcomes (2)

• 3-years Progression Free Survival

  PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.

  3 years after operation.

• 5-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 after operation.

Secondary Outcomes (3)

• 3-years overall survival

  3 years after operation.

• 5-years overall survival

  5 years after operation.

• Complication

  5 years.

Study Arms (2)

Adjuvant chemotherapy combined with maintenance therapy

EXPERIMENTAL

Procedure: Colorectal resection surgery.; Drug: FOLFOX chemotherapy regimen; Drug: Capecitabine

Single adjuvant chemotherapy

SHAM COMPARATOR

Procedure: Colorectal resection surgery.; Drug: FOLFOX chemotherapy regimen

Interventions

Colorectal resection surgery. PROCEDURE

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

Adjuvant chemotherapy combined with maintenance therapy; Single adjuvant chemotherapy

FOLFOX chemotherapy regimen DRUG

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

Also known as: CapeOx chemotherapy regimen

Adjuvant chemotherapy combined with maintenance therapy; Single adjuvant chemotherapy

Capecitabine 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.

Also known as: 5-FU/LV

Adjuvant chemotherapy combined with maintenance therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplastic Cells, Circulating; Neoplasms, Second Primary

Interventions

Folfox protocol; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 4, 2023
• Study Start: February 20, 2023
• Primary Completion (Estimated): February 20, 2029
• Study Completion (Estimated): February 20, 2031
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

CN (1)