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New treatment option for Cholangiocarcinoma
Official title Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
ClinicalTrials.gov ID: NCT07030140
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II, single-arm, prospective clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy combining stereotactic body radiotherapy (SBRT), GP chemotherapy (gemcitabine and cisplatin/oxaliplatin), and tislelizumab in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Eligible patients will receive SBRT followed by three cycles of tislelizumab plus GP chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.