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Biliary Tract Cancer (BTC)Phase 2NCT07638501

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

A Phase 2 study testing Sintilimab + GC and SBRT 7Gy✖️5 QD in people with Biliary Tract Cancer (BTC), run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Cancer (BTC)
What is being tested?
Sintilimab + GC and SBRT 7Gy✖️5 QD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
1 siteChina
Study dates
15 Jun 2026to 15 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Patients voluntarily provide written informed consent, with authorization obtained from the patient or legal representative prior to any protocol-related procedures.
  • Age ≥ 18 years and ≤ 75 years; both female and male
  • Histologically or cytologically confirmed, unresectable advanced or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
  • No prior systemic anti-tumor treatment for BTC. Patients who developed recurrent disease >6 months after surgery with curative intent and, if given, >6 months after the completion of neo/adjuvant therapy (chemotherapy and/or radiation) will be eligible.
  • At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
  • ECOG performance status of 0 or 1.
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  • Life expectancy ≥12 weeks.
  • Adequate organ and bone marrow function within 14 days prior to initiation of study treatment, defined as follows:
  • a.Hematology (without transfusion, granulocyte colony-stimulating factor [G-CSF], or other correction treatment within 14 days prior to screening): i.Hemoglobin [HB] ≥ 90 g/L; ii.Absolute neutrophil count [ANC] ≥ 1.5 × 109/L; iii.platelet count (PLT) ≥ 75 × 109/L b.Biochemistry Examination (without albumin infusion within 14 days prior to screening): i.Total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN) (for patients with Gilbert's syndrome, ≤ 3 × ULN) ii.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN; iii.serum creatinine (Cr) ≤ 1.5 × ULN or clearance of creatinine (CCr) ≥ 50 mL/min (Cockcroft-Gault formula);
  • Male: Creatinine clearance rate = [(140 - age) × weight] / (72 × serum Cr)
  • Female: Creatinine clearance rate= [(140 - age) × weight] / (72 × serum Cr) × 0.85 (Weight unit: kg; serum Cr unit: mg/dL)
  • Patients with evidence of hepatitis B virus (HBV) infection, defined as detectable HBV DNA (≥10 IU/mL or above the lower limit of detection according to local laboratory standards) and positive HBsAg and/or anti-HBc, must receive antiviral therapy prior to study drug administration in accordance with institutional practice to ensure adequate viral suppression. Antiviral therapy must be continued throughout the study period and for at least 6 months after the last dose of study treatment. Patients who are anti-HBc positive but HBV DNA negative (<10 IU/mL or below the lower limit of detection according to local laboratory standards) are not required to receive antiviral therapy unless HBV DNA rises to ≥10 IU/mL or exceeds the local lower limit of detection during study treatment.
  • Female patients of childbearing age must have a documented negative urine or serum pregnancy test within 7 days prior to the first dose. If the urine test result is inconclusive, a serum test must be performed, and the serum result will be considered definitive. Female patients of childbearing age who have sexual intercourse with non-sterilized male partners must agree to take effective contraceptive measures throughout the treatment and 120 days after the last dose.
  • Male patients with female sexual partners of childbearing age must agree to take effective contraceptive measures throughout the treatment and 120 days after the last dose. The decision to discontinue contraception beyond this time frame should be discussed with the investigator.
  • Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.

Who cannot join

  • Histologically or cytologically confirmed rare biliary tract tumors, including ampullary cancer, neuroendocrine tumors, sarcoma, or mucinous cystic neoplasms.
  • Other active malignancy within the past 5 years or concurrent, except adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
  • History of carcinomatous meningitis or brain metastases.
  • Known hypersensitivity or allergic reaction to any study drug or any excipient therein.
  • Participation in another investigational drug clinical trial within the past 3 months or concurrent enrollment in another clinical study, unless observational, non-interventional, or follow-up phase of an interventional study.
  • Uncontrolled concurrent illness, including but not limited to moderate to severe ascites, uncontrolled or moderate-to-large pleural or pericardial effusion, uncontrolled acute or chronic pancreatitis, active hemorrhagic disorder, or severe chronic gastrointestinal disease associated with diarrhea.
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  • History of allogeneic organ or allogeneic bone marrow transplantation.
  • History of significant cardiovascular or cerebrovascular disease, including:
  • congestive heart failure (NYHA Class ≥II), unstable angina, myocardial infarction, uncontrolled arrhythmia, or cerebrovascular accident within 12 months prior to first dose;
  • left ventricular ejection fraction <50%;
  • corrected QT interval (QTc) >480 ms (Fridericia formula);
  • poorly controlled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg based on ≥2 measurements);
  • history of hypertensive crisis or hypertensive encephalopathy.
  • Active autoimmune disease within 2 years prior to first dose or history of autoimmune disease with potential for relapse, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (except hypothyroidism controlled by hormone replacement therapy).
  • Prior anti-cancer therapy-related adverse events not recovered to Grade ≤1 or baseline, with Grade ≤2 neuropathy possibly eligible per investigator assessment.
  • Active infection, including tuberculosis or human immunodeficiency virus (HIV).
  • Diagnosis of immunodeficiency, or chronic systemic steroid therapy (daily dose >10 mg prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of study intervention.
  • History of gastrointestinal bleeding within 6 months prior to study treatment, documented predisposition to gastrointestinal hemorrhage, or known hereditary or acquired bleeding (e.g., coagulopathy) or thrombotic tendency.
  • Major surgery (excluding biopsy) with incomplete recovery from surgery or surgical complications, or incomplete wound healing, prior to start of study intervention, or anticipated need for major surgery during the study period.
  • Receipt of live attenuated vaccine within 28 days prior to first dose of study intervention, or anticipated need for live attenuated vaccine during study treatment or within 60 days after last dose.
  • Any other condition judged by the investigator to potentially interfere with study outcomes or lead to premature study termination, including alcohol or drug abuse, severe comorbidity requiring concomitant therapy (including psychiatric illness), severe laboratory abnormality, or family or social factors affecting patient safety or data collection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Feng Shen contact

+86 13901651428

shenfengehbh@sina.com

China1 site

  • Eastern Hepatobiliary Surgery Hospital

    Shanghai, 201805

Other trials in China

About this study

Official title: Evaluation of the Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) Combined With Gemcitabine, Cisplatin, and Sintilimab as First-Line Therapy for Unresectable Biliary Tract Cancer: A Prospective, Multicenter, Randomized Controlled Study

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.

Being tested
Sintilimab + GC, SBRT 7Gy✖️5 QD
Keywords
First-line Therapy, Stereotactic Body Radiotherapy (SBRT), Immunotherapy
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sintilimab + GCDrug

    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.

  • SBRT 7Gy✖️5 QDRadiation

    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.

Study groups in NCT07638501
Study groupRoleWhat they receive
SBRT+sintilimab+GCExperimentalSBRT: total dose of 35 Gy in 5 fractions (7 Gy per fraction); Followed by Sintilimab (200 mg, iv, d1, q3w) in combination with gemcitabine (1000 mg/m², iv, d1/d8, q3w), cisplatin (25 mg/m², iv, d1/d8, q3w)
Receives: Drug: Sintilimab + GC; Radiation: SBRT 7Gy✖️5 QD
sintilimab+GCActive comparatorSintilimab (200 mg, iv, d1, q3w) combined with gemcitabine (1000 mg/m², iv, d1/d8, q3w) and cisplatin (25 mg/m², iv, d1/d8, q3w)
Receives: Drug: Sintilimab + GC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    The time from the date of randomization to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1), or death due to any cause.

    Measured: Through out the study (up to 3 years)

Secondary outcomes (7)

  1. Progression-free Survival (PFS)

    The time from the date of randomization to the date of the first documented tumor progression as determined by the investigator (per mRECIST), or death due to any cause.

    Measured: Through out the study (up to 3 years)

  2. Objevtive Response Rate (ORR)

    Disease assessments based on investigator assessments were determined by using RECIST v1.1/mRECIST. The ORR was defined as the percentage of patients with complete response (CR) or partial response (PR).

    Measured: Tumor assessments every 6 weeks for the first 48 weeks relative to the date of randomization and then every 12 weeks thereafter. Assessed up to maximum of approximately 3 years.

  3. Disease Control Rate (DCR)

    Disease control rate based on investigator assessments according to RECIST v1.1/mRECIST was defined as the proportion of CR, PR or stable disease (SD).

    Measured: Tumor assessments every 6 weeks for the first 48 weeks relative to the date of randomization and then every 12 weeks thereafter. Assessed up to maximum of approximately 3 years.

  4. Time to Response (TTR)

    The time from randomization to the first evaluation of the tumor as CR, PR (per RECIST v1.1 and mRECIST).

    Measured: Through out the study (up to 3 years)

  5. Duration of Response (DoR)

    The time from the first evaluation of the tumor as CR, PR to the first evaluation as PD (per RECIST v1.1 and mRECIST) or death from any cause.

    Measured: Through out the study (up to 3 years)

  6. Overall Survival (OS)

    The time from the date of randomization until death due to any cause.

    Measured: Through out the study (up to 3 years)

  7. Incidence of Adverse Events (AEs)

    The incidence and severity of adverse events (AEs), serious adverse events (SAEs), immune-related adverse events (irAEs), and laboratory abnormalities, assessed according to the NCI-CTCAE v5.0.

    Measured: Through out the study (up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion15 Jun 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
123 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638501
Sponsor's protocol ID
EHBHKY2026-H008-P001
Status last verified
Jun 2026
First submitted
4 Jun 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab + GC and SBRT 7Gy✖️5 QD in people with Biliary Tract Cancer (BTC), run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Feng Shen (+86 13901651428, shenfengehbh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Through out the study (up to 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07638501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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