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Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
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.
Official title: Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
346
Start Date
2023-02-20
Completion Date
2031-02-20
Last Updated
2023-04-04
Healthy Volunteers
No
Interventions
Colorectal resection surgery.
Colorectal cancer radical resection combined with liver metastasis resection or ablation.
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.
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.
Locations (1)
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China