Neoadjuvant tislelizumab with SBRT and gemcitabine/platinum chemotherapy for borderline or unresectable hilar bile duct cancer
A Phase II, Single-arm, Prospective Clinical Study of Neoadjuvant Therapy With Tislelizumab Combined With Radiotherapy and Gemcitabine-Platinum Chemotherapy for Borderline Resectable or Unresectable Hilar Cholangiocarcinoma
This trial will see if precise radiotherapy (SBRT) followed by the PD‑1 drug tislelizumab plus gemcitabine and platinum chemotherapy can shrink tumors enough to allow surgery and improve survival in people with borderline resectable or unresectable hilar cholangiocarcinoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | tislelizumab, chemotherapy, Immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07030140 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (18–75) with histologically confirmed borderline resectable or unresectable hilar cholangiocarcinoma, ECOG 0–1, adequate blood/liver/kidney function, no distant metastasis, and no prior anti‑tumor therapy for this diagnosis.
Not a fit: Patients with distant metastatic disease, poor performance status, active autoimmune disease requiring systemic therapy, prior checkpoint inhibitor treatment, or significant comorbidities are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could convert more patients to operable status and potentially prolong survival compared with standard nonsurgical care.
How similar studies have performed: Early-phase studies and case series combining PD‑1 inhibitors with chemotherapy and radiotherapy in biliary tract cancers have shown promising response rates, but high‑quality randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinan, Shandong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.