Triple threat: drug cocktail and precision radiation take on tough bile duct cancer
NCT ID NCT07635290
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests a combination of two drugs (anlotinib and cadonilimab) plus a special type of radiation (PULSAR) in 26 people with advanced bile duct cancer that has worsened after standard treatment. The goal is to see if this triple therapy can shrink tumors and control the disease, while monitoring side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anlotinib, Cadonilimab, and PULSAR radiation
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced biliary tract cancer who have run out of standard therapies.
- What could go wrong
- This is a small, early-phase trial with only 26 participants, so results may not apply to everyone. The combination may cause significant side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age: 18-75 years, regardless of gender. * Histopathologically confirmed diagnosis of biliary tract cancer (BTC). * Patients with unresectable or metastatic BTC who have progressed after at least one line of standard systemic therapy * At least one measurable lesion (RECIST v1.1) not previously irradiated. * ECOG Performance Status (PS): 0-1. * Expected survival ≥ 3 months. * Willing and able to comply with study procedures, treatment, and follow-up. * No contraindications to radiotherapy. * Adequate organ function: WBC ≥ 2.5×10⁹/L, ANC ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; Hemoglobin (HGB) ≥ 90 g/L (no transfusion or EPO dependence within 7 days); Total bilirubin (Tbil) ≤ 1.5×ULN; ALT/AST ≤ 5×ULN;Albumin ≥ 30 g/L; INR ≤ 1.5×ULN; Serum creatinine (Cr) ≤ 1.5×ULN;Urine protein ≤ 1+ * Prior immunotherapy must have been discontinued for at least 4 weeks (to avoid cross-reactivity). * Voluntary participation with signed informed consent form. Exclusion Criteria: * History of severe allergic reactions to chimeric, human, or humanized antibodies, or fusion proteins. * Pregnant or lactating women; men or women of childbearing potential who are unwilling or unable to use effective contraception. * History of other malignancies within the past 5 years, except for: malignancies treated with curative intent with no known active disease for ≥ 5 years prior to first dose and with low potential risk of recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease. * Clinically symptomatic moderate to large volume pleural or peritoneal effusion. * Active bleeding or coagulopathy (PT \> 16 s, APTT \> 43 s, INR \> 1.5 × ULN), bleeding tendency, or ongoing thrombolytic, anticoagulant, or antiplatelet therapy. * History of gastrointestinal bleeding within the past 6 months, or clear evidence of gastrointestinal bleeding tendency, such as: known active localized ulcerative lesions, fecal occult blood ≥ 2+ (patients with persistent fecal occult blood 1+ should undergo gastroscopy). * Severe gastric or esophageal varices requiring interventional treatment. * Untreated active hepatitis B. (Note: Subjects with hepatitis B who are receiving antiviral therapy and have HBV viral load \< 2000 IU/mL may be permitted to participate in the study.) * Active hepatitis C, defined as positive anti-HCV antibody or positive HCV-RNA with abnormal liver function. * History of psychoactive substance abuse that cannot be discontinued, or history of psychiatric disorders. * History of solid organ or bone marrow transplantation, or active autoimmune disease requiring systemic treatment within 2 years prior to first dose. * Known immunodeficiency disease or HIV infection. * Objective evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function. * Major surgery (e.g., hepatic or other site) within 4 weeks prior to first dose, or minor surgery (e.g., simple excision, tooth extraction) within 1 week prior to first dose. * Receipt of vaccination within 30 days prior to first dose. * Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to first dose. * Any clinically significant laboratory or physical abnormality that, in the investigator's opinion, may affect safety evaluation, such as: active infection requiring systemic treatment, uncontrolled diabetes, hypertension that cannot be controlled to within normal range (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg) after treatment with ≤ 2 antihypertensive drugs, myocardial infarction within the past 6 months, thyroid dysfunction ( \> NCI CTCAE v5.0 Grade 1), etc. * Any other condition that the investigator considers inappropriate for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.