ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

NCT05815082 | Recruiting Phase 3 DMC

• 1 other identifier: 1010(CG)2022-02
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.

Conditions

Colorectal Cancer; Liver Metastases; Circulating Tumor Cell; Chemotherapy Effect

Keywords

Colorectal Cancer; Liver Metastases; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (2)

• 3-year 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-year 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-year overall survival

  3 years after operation.

• 3-year overall survival

  5 years after operation.

• Complications

  5 years.

Study Arms (2)

Watching and waiting group

EXPERIMENTAL

Watch and Wait strategy is one of the treatment strategies of advanced rectal cancer, which recommends no immediate surgery with close surveillance.

Procedure: Colorectal cancer resection combined with liver metastasis resection.

Adjuvant chemotherapy group

ACTIVE COMPARATOR

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

Procedure: Colorectal cancer resection combined with liver metastasis resection.; Drug: FOLFOX chemotherapy regimen

Interventions

Colorectal cancer resection combined with liver metastasis resection. PROCEDURE

The preferred surgical approach is resection of the corresponding colon segment with regional lymph node dissection. If conditions permit, synchronous resection of the primary lesion and liver metastases of colorectal cancer can be performed to achieve curative resection.

Adjuvant chemotherapy group; Watching and waiting group

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 group

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 genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
• Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
• Patients with negative ctDNA after surgery;
• ASA grade \<IV and/or ECOG performance status score ≤ 2;
• Have sufficient understanding of the study and voluntarily sign an informed consent form.

You may not qualify if:

• Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
• Patients with a history of other malignancies;
• Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
• Patients who are allergic to any component in the study;
• Patients who have received other tumor-related investigational drug therapy;
• Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
• Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests;
• Patients with a history of severe mental illness;
• Pregnant or lactating women;
• Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.

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

Interventions

Folfox protocol

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

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 18, 2023
• Study Start: February 20, 2023
• Primary Completion (Estimated): February 20, 2031
• Study Completion (Estimated): February 20, 2033
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)