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OpenTrials
Completed

NCT Number: NCT06027775

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • R1/R2 resection;
  • Extrahepatic metastases;
  • Accepted postoperative monotherapy;
  • Lack of follow-up data.

Treatment and study plan

Targeted agent

Drug

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

Primary outcomes

  1. relapse-free survival

    Time frame: 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 outcomes

  1. overall survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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