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

Colorectal Cancer Metastatic Clinical Trial

Official title:

Chemotherapy Alone Versus Chemotherapy Plus Targeted Therapy as Adjuvant Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06027775
• Other study ID #: CAPTIUM
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• Targeted agent
The two cohorts received different adjuvant therapy regimens, with the CT group receiving chemotherapy plus targeted therapy; the CA group received chemotherapy alone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse-free survival	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	3 years
Secondary	overall survival	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.	5 years