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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06027775
Other study ID # CAPTIUM
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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