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

ConditionsCholangiocarcinomaHilar CholangiocarcinomaBile Duct Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJinbo Yue

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Evidence of distant metastasis

Prior treatment with immune checkpoint inhibitors

Uncontrolled infection or serious medical comorbidities

Active autoimmune disease requiring systemic therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • Tislelizumab

    Drug

    Tislelizumab 200 mg administered intravenously every 3 weeks (on Day 1 of each 21-day cycle), for three to six cycles depending on surgical eligibility.

  • Gemcitabine

    Drug

    Gemcitabine 1000 mg/m² administered intravenously on Days 1 and 8 of each 21-day cycle, for three to six cycles.

  • Cisplatin or Oxaliplatin

    Drug

    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 three to six cycles.

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Tislelizumab + SBRT + GP ChemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Defined as the time from initiation of treatment to death from any cause.

Time frame
Up to 36 months

Secondary outcomes

1

R0 Resection Rate

Proportion of patients achieving microscopically margin-negative (R0) resection among those undergoing surgery.

Time frame
At the time of surgery (approx. 3-6 months from enrollment)
2

Pathological Complete Response (pCR)

Absence of residual viable tumor cells in resected specimens.

Time frame
At the time of surgery
3

Progression-Free Survival (PFS)

Time from initiation of treatment to disease progression or death from any cause.

Time frame
Up to 24 months
4

Local Control Rate

Proportion of patients without local tumor progression at irradiated site.

Time frame
6, 12, 18, and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinbo Yue

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution

Source ClinicalTrials.gov
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