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

NCT06027775 | Completed FDA Drug

• 1 other identifier: CAPTIUM
• Study Type: observational
• Target: 198
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall survival

  5 years

Study Arms (2)

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.

Drug: Targeted agent

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.

Interventions

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.

Chemotherapy plus Targeted therapy (CT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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）.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Officials

• Jianmin Xu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Colorectal Surgery

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: January 1, 2013
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share