NCT05797077

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

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Colorectal resection surgery.	Colorectal cancer radical resection combined with liver metastasis resection or ablation.
DRUG	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.
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.

Timeline

• Start date: 2023-02-20
• Primary completion: 2029-02-20
• Completion: 2031-02-20
• First posted: 2023-04-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: China