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Triple threat: drug cocktail and precision radiation take on tough bile duct cancer

NCT ID NCT07635290

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

biliary tract cancer Biliary Tract Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.