NCT05815082

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (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 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

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2023-02-20
• Primary completion: 2031-02-20
• Completion: 2033-02-20
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: China