Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment f… (NCT07638501) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer
China123 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines radiation (SBRT), two chemotherapy drugs (gemcitabine and cisplatin), and an immunotherapy drug (sintilimab) all at once — given how many treatments are being combined, what side effects should I realistically prepare for compared to standard chemotherapy alone?
2Since this is a Phase 2 trial, what do we actually know so far about whether this combination is safe and effective for biliary tract cancer, and what would we not yet know that a larger Phase 3 trial would tell us?
3The trial isn't recruiting yet — how long might it be before it opens, and is waiting for it a reasonable option given my current stage and how quickly my cancer may need to be treated?
4The main thing this trial is measuring is progression-free survival, meaning how long before the cancer grows or spreads — does that outcome matter most for my specific situation, or should I be asking about overall survival or quality of life as my primary goals?
5Would starting standard first-line treatment now with gemcitabine and cisplatin make me ineligible for this trial later, or is it worth discussing whether to wait and see if this study becomes available near me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adequate organ and bone marrow function within 14 days prior to initiation of study treatment, defined as follows:
Exclusion criteria
. 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.
. History of allogeneic organ or allogeneic bone marrow transplantation.
. History of significant cardiovascular or cerebrovascular disease, including: