DEB-TACE combined with apatinib and camrelizumab as second-line therapy for unresectable intrahepatic cholangiocarcinoma: A prospective, single-arm, phase II study.

4164 Background: This study aimed to evaluate the efficacy and safety of drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with Apatinib and Camrelizumab as second-line therapy for unresectable intrahepatic cholangiocarcinoma (ICC). Methods: This is a prospective, single-arm, phase II study. Eligible patients were those with unresectable ICC who had progressed after first-line gemcitabine-containing chemotherapy. These patients received DEB-TACE combined with Apatinib and Camrelizumab therapy. The primary endpoints were to assess the objective response rate (ORR) and disease control rate (DCR) in accordance with both Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 and modified RECIST (mRECIST) criteria. Secondary objectives included measuring progression-free survival (PFS), overall survival (OS), and safety profiles. Adverse events (AEs) were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Results: Twenty patients participated in this study. The ORR was 65% (95% confidence interval [CI]: 40.8%–84.6%) per mRECIST and 25% (95% CI: 8.7%–49.1%) per RECIST V1.1. The DCR was 95% (95% CI: 74%–99%) per mRECIST and 85% (95% CI: 62.1%–96.8%) per RECIST V1.1. The median PFS was 7.7 (95% CI: 5.5–9.8) months. The median OS was 13.2 (95% CI: 3.1–23.3) months. Treatment-related adverse events (TRAEs) occurred in all 20 (100%) patients. The most common TRAEs included decreased lymphocyte count, hypertension, and abdominal pain, with grade ≥3 TRAEs manageable via appropriate interventions. Conclusions: DEB-TACE combined with Apatinib and Camrelizumab as second-line therapy for unresectable ICC demonstrated promising efficacy and an acceptable safety profile, providing a viable treatment option for patients with unresectable ICC progressing after first-line gemcitabine-containing chemotherapy. Clinical trial information: NCT04834674 .