Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer

June 3, 2026 updated by: Wang Xin, West China Hospital

A Phase II Clinical Trial of Anlotinib Combined With Cadonilimab and PULSAR in Previously Treated Advanced Unresectable or Metastatic Biliary Tract Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib + Cadonilimab + PULSAR
Radiation: PULSAR
Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy
Drug: Anlotinib + Cadonilimab
Anlotinib Combined with Cadonilimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (RECIST v1.1)
Time Frame: From the first patient enrollment until 6 months after the last patient enrollment
From the first patient enrollment until 6 months after the last patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From the first patient enrollment until 6 months after the last patient enrollment
From the first patient enrollment until 6 months after the last patient enrollment
Overall survival
Time Frame: From the first patient enrollment until 6 months after the last patient enrollment
From the first patient enrollment until 6 months after the last patient enrollment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: From the first patient enrollment until 6 months after the last patient enrollment
the incidence of adverse events (AE) or severe adverse events (SAE) assessed by CTCAE v5.0
From the first patient enrollment until 6 months after the last patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Collaborators

Akeso
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIM-C2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will not be shared in order to protect participant confidentiality, in compliance with local data protection regulations and ethical committee requirements. Additionally, IPD sharing is restricted under contractual agreements with study sponsors/partners, who retain data ownership for independent analyses. Given the complexity and size of the dataset (e.g., genomic/imaging data), anonymized IPD sharing is technically unfeasible without risking data integrity. Furthermore, to safeguard intellectual property rights and permit ongoing secondary analyses by the research team, IPD will be retained internally.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Biliary Tract Cancers

Clinical Trials on PULSAR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe