Neoadjuvant tislelizumab with SBRT and gemcitabine/platinum chemotherapy for borderline or unresectable hilar bile duct cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single‑arm, prospective phase II trial that gives stereotactic body radiotherapy (SBRT) to the tumor followed by three cycles of tislelizumab combined with gemcitabine and a platinum agent (cisplatin or oxaliplatin). Patients whose tumors become resectable after this neoadjuvant regimen may undergo surgery and receive postoperative care per the multidisciplinary team; those who remain unresectable continue systemic therapy. The primary endpoint is overall survival, with secondary endpoints including R0 resection rate, pathological complete response, surgical difficulty, progression‑free survival, local control, and treatment safety. Eligibility focuses on adults with histologically confirmed borderline resectable or unresectable hilar cholangiocarcinoma, good performance status, and adequate organ function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years, histologically or cytologically confirmed hilar cholangiocarcinoma
* Borderline resectable or unresectable disease based on imaging and MDT evaluation
* ECOG performance status 0-1
* Adequate hematologic, hepatic, and renal function
* No prior anti-tumor therapy for current diagnosis
* Expected survival ≥ 3 months
* Signed informed consent

Exclusion Criteria:

* Evidence of distant metastasis
* Prior treatment with immune checkpoint inhibitors
* Uncontrolled infection or serious medical comorbidities
* Active autoimmune disease requiring systemic therapy
* History of organ transplantation or immunodeficiency
* Pregnancy or lactation

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jinbo Yue — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue
• Email: jbyue@sdfmu.edu.cn
• Phone: 053167626442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.