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Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer

NCT07638501 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-06-10

No results posted yet for this study

Summary

According to current clinical guidelines, first-line treatment for advanced biliary tract cancer (BTC) is the gemcitabine plus cisplatin (GC) regimen combined with immunotherapy, which has been shown to improve patient outcomes. Additionally, the combination of radiotherapy and immunotherapy may synergistically enhance antitumor efficacy. Therefore, this study aims to assess the efficacy and safety of first-line treatment with radiotherapy in combination with sintilimab and gemcitabine/cisplatin versus sintilimab in combination with gemcitabine/cisplatin in patients with previously untreated, unresectable locally advanced or metastatic BTC.

Conditions

  • Biliary Tract Cancer (BTC)

Interventions

DRUG

Sintilimab + GC

Participants receive sintilimab (200 mg, intravenous \[IV\], day 1), gemcitabine (1000 mg/m², IV, day 1 and day 8), and cisplatin (25 mg/m², IV, day 1 and day 8) every 3 weeks (q3w). The drugs are administered sequentially with an interval of \>30 minutes between each, preferably on the same day. Different drugs require separate infusion bags and filters.

RADIATION

SBRT 7Gy✖️5 QD

Stereotactic body radiotherapy (SBRT) is delivered only to participants in the experimental arm with total dose of 35 Gy in 5 fractions (7 Gy per fraction). SBRT is completed within 1 week before the first cycle of sintilimab+GC.

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    lead OTHER

Principal Investigators

  • Feng Shen · Eastern Hepatobiliary Surgery Hospital

  • Ruiliang Ge · Eastern Hepatobiliary Surgery Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-06-15
Completion
2029-06-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638501 on ClinicalTrials.gov