HAIC plus TAE combined with tislelizumab and surufatinib in unresectable intrahepatic cholangiocarcinoma: The REACH-01 trial.

4087 Background: REACH-01 (NCT06239532) is a single-arm, open label, prospective trial, aiming to evaluate the safety and preliminary effectiveness of hepatic artery infusion chemotherapy (HAIC) plus transcatheter arterial embolization (TAE) combined with tislelizumab and surufatinib as first-line therapy for unresectable intrahepatic cholangiocarcinoma (iCCA). Methods: Twenty-eight patients with pathologically confirmed iCCA received TAE with undrugged microspheres and hepatic arterial infusion of oxaliplatin (85 mg/m 2 ) and raltitrexed (3 mg/m 2 ) at an interval of at least 3 weeks along with intravenous tislelizumab (200 mg) Q3W and oral surufatinib (150 - 250 mg) once daily. The primary endpoint was the objective response rate (ORR). Secondary outcomes included progression-free survival (PFS), conversion to surgical resection rate, overall survival (OS), 1-year OS rate, disease control rate (DCR), and incidence of adverse events. Results: As of December 18, 2024, the median follow-up time was 9.33 months, 15 patients achieved partial response and the ORR was 57.69 % per RECIST v1.1 criteria. The conversion to surgical resection rate was 15.38 %. The DCR was 80.77 %. Secondary endpoints of progression-free survival, overall survival and 1-year OS rate were not mature at the time of the analysis. Further, treatment related adverse effects (TRAEs) of any grade occurred in 28 patients. Manageable grade 3 adverse events (AEs) occurred in 32.14% of patients, commonly elevated alanine aminotransferase (7.14%), anorexia (7.14%), and hypokalemia (7.14%). Conclusions: HAIC plus TAE combined with tislelizumab and surufatinib are safe and promising first-line treatment selection for unresectable iCCA. Clinical trial information: NCT06239532 .