Chemotherapy Alone Versus Chemotherapy Plus Targeted Therapy as Adjuvant Therapy for Initially Unresectable Colorectal Cancer Liver Metastases

Completed

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Targeted agent

• Registration Number: NCT06027775
• Lead Sponsor: Fudan University

Brief Summary

Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with a tolerable toxicity profile.

Detailed Description

This multi-center study enrolled consecutive patients with initially unresectable CRLM who underwent conversion therapy or radiofrequency ablation (RFA) and achieved no NED status between June 1, 2013, and June 30, 2020, from Zhongshan Hospital of Shanghai, Zhongshan Hospital of Xiamen, Cancer Hospital of Beijing. The inclusion criteria were as follows: (1) with histologically confirmed CRC; (2) with initially unresectable synchronous liver metastases (LMs); (3) accepted conversion therapy and successfully converted into resectable status; (4) underwent R0 intestinal and hepatic resection; (5) accepted adjuvant therapy. The exclusion criteria were as follows: (1) R1/R2 resection; (2) extrahepatic metastases; (3) accepted postoperative monotherapy; (4) lack of follow-up data. According to the adjuvant therapy regimen (with or without targeted therapy), the cohorts were divided into CA cohort and CT cohort. The study was approved by the ethics committee of three medical centers and was adhered to Good Clinical Practice guidelines and the Declaration of Helsinki. Written informed consent was obtained from all participants.

Study Timeline

• Study Start: 2013-01-01
• Status Verified: 2023-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years;
2. Histologically confirmed CRC;
3. Initially unresectable synchronous liver metastases (LMs);
4. Accepted conversion therapy and successfully converted into resectable status;
5. Underwent R0 intestinal and hepatic resection;
6. Accepted adjuvant therapy.

Exclusion Criteria

1. R1/R2 resection;
2. Extrahepatic metastases;
3. Accepted postoperative monotherapy;
4. Lack of follow-up data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy plus Targeted therapy (CT)	Targeted agent	The treatment decisions and evaluation of treatment outcomes, such as the assessment of metastases resectability and tumor response, were carried out by the multi-disciplinary team (MDT) comprising experts from each medical centers. In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy plus targeted therapy, as adjuvant therapy.

Primary Outcome Measures

Name	Time	Method
relapse-free survival	3 years	The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years	The overall survival (OS) was defined as the period from the start of initial liver resection until death from any cause, at which point the data was censored.