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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06027775
Enrollment
198
Registered
2023-09-07
Start date
2013-01-01
Completion date
2023-01-01
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Metastatic

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.

Interventions

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

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
relapse-free survival3 yearsThe 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

MeasureTime frameDescription
overall survival5 yearsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026