Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma

Launched by JINBO YUE · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with a type of bile duct cancer called hilar cholangiocarcinoma, which is located near where the liver’s bile ducts join. The trial is testing whether combining a focused form of radiation therapy, chemotherapy (using drugs called gemcitabine and cisplatin or oxaliplatin), and a medicine called tislelizumab (which helps the immune system fight cancer) before surgery can help shrink the tumor and improve outcomes. The goal is to see if this combination can make tumors that are hard to remove with surgery easier to operate on, improve survival, and be safe for patients.

People who might be eligible are adults aged 18 to 75 who have been diagnosed with this specific bile duct cancer and whose tumors are either borderline removable or not removable based on scans and doctors’ evaluations. Participants should be generally healthy enough to handle treatment and have not had previous cancer treatments for this disease. If accepted into the study, patients will first receive targeted radiation, followed by three cycles of the combined medicine and chemotherapy. After this, doctors will check if surgery is possible. If the tumor can be removed, surgery will be done, followed by additional treatment as needed. If surgery isn’t possible, patients will continue with more therapy. This study is not yet recruiting, but it aims to find better ways to treat this challenging cancer and improve patients’ chances of successful surgery and longer survival.

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ALL

Eligibility criteria

• 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