ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Sixth Affiliate Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2033-02-20
Participants
Target number of participants: 490
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials