Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer (NCT07635290) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer
China26 participantsStarted 2026-06-03
Plain-language summary
This study aims to evaluate the safety and preliminary efficacy of anlotinib combined with cadonilimab and PULSAR in previously treated advanced unresectable or netastatic biliary tract cancer.
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:
* 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…
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 is no longer recruiting — does that mean I've already missed the window to join, and are there any similar trials still open that combine immunotherapy with targeted therapy for biliary tract cancer?
2The trial uses three treatments together — anlotinib, cadonilimab, and something called PULSAR — can you explain what each of these does and why combining all three might be more beneficial or more risky than using them separately?
3Since this is a Phase 2 trial measuring objective response rate, what does that mean in terms of how much is already known about whether this combination is safe and actually works for biliary tract cancer?
4I've already had prior treatment for my biliary tract cancer — how would my specific treatment history affect whether this kind of approach might still be worth pursuing, or would standard second-line options be a better fit for me right now?
5If my tumor shrinks according to the RECIST criteria they're measuring, does that automatically mean I'd feel better or live longer, or is that something that would still need more time and study to know for certain?
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.
What they're measuring
1
Objective response rate (RECIST v1.1)
Timeframe: From the first patient enrollment until 6 months after the last patient enrollment