CholangiocarcinomaPhase 2NCT07030140
Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
A Phase 2 study testing Stereotactic Body Radiotherapy (SBRT), Tislelizumab and Gemcitabine in people with Cholangiocarcinoma and Hilar Cholangiocarcinoma, run by Jinbo Yue at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma, Hilar Cholangiocarcinoma, Bile Duct Cancer
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT), Tislelizumab and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jan 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Jinbo MD, doctor, 053167626442, jbyue@sdfmu.edu.cn
About this study
Official title: 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 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. Patients with resectable disease after evaluation may undergo surgery and receive postoperative treatment as recommended by the multidisciplinary team. Those who remain unresectable will receive three additional cycles of systemic therapy. The primary endpoint is overall survival (OS); secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, progression-free survival (PFS), local control rate, and treatment-related safety.
Read the detailed description
Hilar cholangiocarcinoma is a rare but highly aggressive malignancy, often diagnosed at advanced stages due to its asymptomatic progression and challenging anatomical location. R0 resection remains the cornerstone of curative therapy, but many patients are initially considered borderline resectable or unresectable due to vascular involvement or lymph node metastasis.
Recent studies suggest that neoadjuvant therapy may improve resectability and survival outcomes by reducing tumor burden and modulating the tumor microenvironment. Stereotactic body radiotherapy (SBRT) offers precise local control, while GP chemotherapy (gemcitabine and cisplatin/oxaliplatin) has demonstrated efficacy in biliary tract cancers. Immunotherapy with PD-1 inhibitors, such as tislelizumab, has shown promise in enhancing antitumor immunity, especially when combined with radiotherapy and chemotherapy.
This phase II, single-arm, prospective study aims to evaluate the efficacy and safety of neoadjuvant SBRT followed by tislelizumab and GP chemotherapy in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Patients will first receive SBRT to the gross tumor volume (GTV) at a dose of either 5Gy × 5-8 fractions or 4Gy × 15 fractions. After radiotherapy, participants will receive three cycles of tislelizumab (200mg Q3W) in combination with gemcitabine (1000mg/m² on Days 1 and 8) and cisplatin (25mg/m² on Days 1 and 8) or oxaliplatin (100mg/m² on Day 1), repeated every 21 days.
Patients will be re-evaluated after three cycles. If resectable, patients may undergo surgery, followed by additional postoperative therapy based on MDT recommendations. If unresectable, an additional three cycles of systemic therapy will be administered. The primary endpoint is overall survival (OS). Secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, local control rate, progression-free survival (PFS), and treatment-related adverse events.
- Being tested
- Stereotactic Body Radiotherapy (SBRT), Tislelizumab, Gemcitabine, Cisplatin or Oxaliplatin
- Keywords
- Borderline Resectable, Unresectable, SBRT, Tislelizumab, Gemcitabine, Cisplatin, Oxaliplatin, Neoadjuvant Therapy, Immunotherapy, Radiation Therapy, PD-1 Inhibitor, Biliary Tract Cancer
- Medical subject headings
- Cholangiocarcinoma, Klatskin Tumor, Bile Duct Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy (SBRT)Radiation
SBRT to the primary tumor and metastatic lymph node at a dose of either 5 Gy × 5-8 fractions or 4 Gy × 15 fractions, delivered prior to systemic therapy.
TislelizumabDrug
Tislelizumab 200 mg administered intravenously every 3 weeks (on Day 1 of each 21-day cycle), for six cycles depending on surgical eligibility.
GemcitabineDrug
Gemcitabine 1000 mg/m² administered intravenously on Days 1 and 8 of each 21-day cycle, for six cycles.
Cisplatin or OxaliplatinDrug
Cisplatin 25 mg/m² on Days 1 and 8 or oxaliplatin 100 mg/m² on Day 1 of each 21-day cycle, selected based on patient condition, for six cycles.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab + SBRT + GP Chemotherapy | Experimental | Participants will receive neoadjuvant hypofractionated radiotherapy followed by six cycles of combination therapy with tislelizumab and GP chemotherapy.
RT: 5 Gy × 5-8 fractions or 3.5-4.0 Gy × 15 fractions to the primary tumor. Tislelizumab: 200 mg intravenously every 3 weeks (Day 1 of each cycle). Gemcitabine: 1000 mg/m² IV on Days 1 and 8 of each 21-day cycle. Cisplatin: 25 mg/m² IV on Days 1 and 8 OR Oxaliplatin: 100 mg/m² IV on Day 1 (based on clinical condition). After six cycles, patients will undergo tislelizumab maintainese (Totally one year). Receives: Radiation: Stereotactic Body Radiotherapy (SBRT); Drug: Tislelizumab; Drug: Gemcitabine; Drug: Cisplatin or Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Defined as the time from initiation of treatment to death from any cause.
Measured: Up to 36 months
Secondary outcomes (5)
R0 Resection Rate
Proportion of patients achieving microscopically margin-negative (R0) resection among those undergoing surgery.
Measured: At the time of surgery (approx. 3-6 months from enrollment)
Pathological Complete Response (pCR)
Absence of residual viable tumor cells in resected specimens.
Measured: At the time of surgery
Progression-Free Survival (PFS)
Time from initiation of treatment to disease progression or death from any cause.
Measured: Up to 24 months
Local Control Rate
Proportion of patients without local tumor progression at irradiated site.
Measured: 6, 12, 18, and 24 months
Treatment-related Adverse Events
Frequency and severity of adverse events graded by CTCAE v5.0.
Measured: From treatment initiation up to 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm design with sequential SBRT followed by Tislelizumab plus GP chemotherapy
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinbo Yue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinbo Yue, Shandong Cancer Hospital and Institute
- Investigators
- Jinbo Yue, Principal investigator, Shandong Cancer Hospital and InstituteBo Zhang, Study chair, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030140
- Sponsor's protocol ID
- SDZLEC2024-364-03
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No