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

NCT ID: NCT06027775

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2023-01-01

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.

Conditions

Colorectal Cancer Metastatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Chemotherapy plus Targeted therapy (CT)

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.

Targeted agent

Intervention Type: DRUG

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

Chemotherapy Alone (CA)

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, as adjuvant therapy.

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Head of Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianmin Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Other Identifiers

CAPTIUM

Identifier Type: -

Identifier Source: org_study_id