NCT07471165

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Locally Advanced Perihilar Cholangiocarcinoma

Interventions

Type	Name	Description
PROCEDURE	PD -1/PD-L1 monoclonal antibody plus radiotherapy and liver transplantation	After receiving treatment with a regimen combining PD-L1 inhibitor, gemcitabine, and cisplatin, patients underwent radiotherapy while concurrently taking oral capecitabine, followed by maintenance therapy with capecitabine until liver transplantation.

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-03-01
• Completion: 2029-07-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

2 sites across 1 country: China