Spots Global Cancer Trial Database for Combined HAIC, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

Study Description

Brief Summary: This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of hepatic artery infusion chemotherapy combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.

Detailed Description: Pucotenlimab is a new humanized PD-1-specific monoclonal antibody. On September 29, 2022, the National Medical Products Administration of China approved the marketing application of Pucotenlimab Injection for the treatment of patients with microsatellite highly unstable (MSI-H)/mismatch repair function defective (dMMR) solid tumors who have failed prior first-line and above systemic therapy. There have been studies and reports on systemic chemotherapy with GEMOX regimen combined with lenvatinib and PD-1 monoclonal antibody for the treatment of intrahepatic cholangiocarcinoma. Currently, a multicenter, phase 2 study evaluating the efficacy of pucotenlimab in patients with mismatch repair-deficient (dMMR) or microsatellite instabilityhigh (MSI-H) tumors is underway. The objective response rate (ORR) is 49.0% (95% CI 38.86%-59.20%), while the median progression-free survival and overall survival have not been reached. Grade ≥3 treatment-related adverse events were observed in 18 of 100 patients. The efficacy of this antibody in patients is promising. Based on the results of these previous studies, this study intends to evaluate the efficacy and safety of hepatic artery infusion chemotherapy (GEMOX regimen) combined with lenvatinib and pucotenlimab in the down-stage conversion treatment of patients with unresectable intrahepatic cholangiocarcinoma.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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