An observational study in Colorectal Cancer Metastatic, sponsored by Fudan University. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Fudan University · Observational
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.
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.
Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.
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Initially unresectable CRLM patients who were successfully converted and achieved no evidence of disease status from June 2013 to June 2020 were retrospectively collected. 1:2 propensity score matching (PSM) was performed to balance the baseline characteristics between CA and CT cohorts. After PSM, 196 patients werethe disease-free survival (DFS) and overall survival (OS) were evaluated between two cohorts （CA:N=66, CT:N=132）.
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Exclusion Criteria:
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.
Drug: Targeted agent
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.
The two cohorts received different adjuvant therapy regimens, with the CT group receiving chemotherapy plus targeted therapy; the CA group received chemotherapy alone.
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
Time frame: 3 years
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.
Time frame: 5 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2013 to primary completion in Jan 2023, 120 months.
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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