Anlotinib plus sintilimab as first-line treatment for patients with advanced colorectal cancer (APICAL-CRC): an open-label, single-arm, phase II trial.

ABSTRACT: This is an investigator-initiated, open-label, single-arm, phase II trial that aimed to assess the combination of sintilimab plus anlotinib among patients with treatment-naïve metastatic colorectal cancer (mCRC) (APICAL-CRC ClinicalTrials.gov number, NCT04271813). Between June 2020 and September 2023, a total of 30 patients were eventually enrolled and received the study regimen. Among these 30 patients, 50% had an Eastern Cooperative Oncology Group(ECOG) score of 0-1, and the other 50% had a score of 2. The objective response rates (ORRs) were 48.3% (95% CI 29.4-67.5) in the efficacy-evaluable cohort and 46.7% (95% CI 28.3-65.7) in the intent-to-treat (ITT) cohort. Twelve patients had stable disease, and the disease control rates (DCRs) were 89.7% (95% CI 72.6-97.8) and 86.7% (95% CI 69.3

SUBMITTER: Wang Z 

PROVIDER: S-EPMC12436658 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature