NEO-ERA-01 Trial

Uses

Dosage & preparation

Background

Evidence quality

Highlighted claims

• NEO-ERA-01 is a prospective, multicentre, single-arm phase II feasibility trial conducted in China using Simon's two-stage design. — Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial
• The trial was initiated in December 2023 and is expected to complete by end of 2026. — Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial
• The primary endpoint is the proportion of patients who complete at least two neoadjuvant cycles and then undergo curative-intent resection. — Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial
• Total planned enrollment is 30 patients, accounting for a 10% dropout rate. — Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial
• The trial will disseminate findings through peer-reviewed publications regardless of whether the hypothesis is confirmed. — Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial
• The Stage 1 interim analysis is planned approximately 8 months after the first patient is enrolled, or when 12 patients complete neoadjuvant evaluation. — Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial
• A single-arm design is justified because no established neoadjuvant standard exists for ICC. — Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial
• Exploratory analyses in NEO-ERA-01 aim to identify biomarkers that predict benefit from neoadjuvant immunotherapy in ICC. — Neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with GEMOX and lenvatinib in combination with adebrelimab for resectable high-risk recurrent intrahepatic cholangiocarcinoma (ICC): study protocol of the NEO-ERA-01 feasibility trial