ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

NCT ID: NCT05815082

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2033-02-20

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

Study Design

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

Study Groups

Watching and waiting group

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

Group Type: EXPERIMENTAL

Colorectal cancer resection combined with liver metastasis resection.

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Colorectal cancer resection combined with liver metastasis resection.

Intervention Type: 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.

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 cancer resection combined with liver metastasis resection.

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.

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

Other Intervention Names

CapeOx chemotherapy regimen

Eligibility Criteria

Inclusion Criteria

1. Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;

2. 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);

3. Patients with negative ctDNA after surgery;

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

5. Have sufficient understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria

1. Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;

2. Patients with a history of other malignancies;

3. Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;

4. Patients who are allergic to any component in the study;

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

6. Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;

7. 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;

8. Patients with a history of severe mental illness;

9. Pregnant or lactating women;

10. Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.

• 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(CG)2022-02

Identifier Type: -

Identifier Source: org_study_id