A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridge Therapy to Liver Transplantation for Locally Advanced Perihilar Cholangiocarcinoma (ACHIEVE-LT)

This study is a prospective, single-arm, phase II clinical trial designed to evaluate the safety and efficacy of PD-L1 monoclonal antibody combined with chemoradiotherapy as a bridge to liver transplantation in patients with locally advanced unresectable perihilar cholangiocarcinoma (pCCA).

Patients with locally advanced, unresectable pCCA who met the criteria as assessed by a multidisciplinary team (MDT) were enrolled after signing informed consent. They received three cycles of treatment with a PD-L1 monoclonal antibody combined with a gemcitabine + cisplatin regimen, followed by external beam radiotherapy (45 Gy/15 fractions) administered concurrently with oral capecitabine. Subsequently, they entered a maintenance therapy phase with capecitabine until liver transplantation (with a minimum of 4 weeks of discontinuation of immunotherapy prior to transplantation) or until disease progression/intolerable toxicity occurred. Within two weeks prior to liver transplantation, a PET-CT scan was performed to exclude distant and occult metastases. Patients who passed the PET-CT staging screening and reached the drug washout period proceeded to the transplantation pathway. Postoperatively, a standard immunosuppressive regimen was adopted, and oral capecitabine was administered for eight cycles as adjuvant therapy. All patients were followed up as scheduled to monitor for recurrence and survival.