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Previously Treated, AdvancedPhase 2NCT07635290

Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer

A Phase 2 study testing Anlotinib + Cadonilimab and PULSAR in people with Previously Treated, Advanced and Biliary Tract Cancers, run by West China Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Anlotinib + Cadonilimab and PULSAR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteChina
Study dates
3 Jun 2026to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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).
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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.

Being tested
Anlotinib + Cadonilimab, PULSAR
Keywords
immunotherapy, targeted therapy, radiotherapy, BTC
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib + CadonilimabDrug

    Anlotinib Combined with Cadonilimab

  • PULSARRadiation

    Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy

Study groups in NCT07635290
Study groupRoleWhat they receive
Anlotinib + Cadonilimab + PULSARExperimentalNot described
Receives: Drug: Anlotinib + Cadonilimab; Radiation: PULSAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (RECIST v1.1)

    Measured: From the first patient enrollment until 6 months after the last patient enrollment

Secondary outcomes (3)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    the incidence of adverse events (AE) or severe adverse events (SAE) assessed by CTCAE v5.0

    Measured: From the first patient enrollment until 6 months after the last patient enrollment

  2. Progression free survival

    Measured: From the first patient enrollment until 6 months after the last patient enrollment

  3. Overall survival

    Measured: From the first patient enrollment until 6 months after the last patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start3 Jun 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07635290
Sponsor's protocol ID
PRIM-C2
Status last verified
Jun 2026
First submitted
3 Jun 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • Moore C, Hsu CC, Chen WM, Chen BPC, Han C, Story M, Aguilera T, Pop LM, Hannan R, Fu YX, Saha D, Timmerman R. Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Preclinical Models Enhances Single-Agent Immune Checkpoint Blockade. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1306-1316. doi: 10.1016/j.ijrobp.2021.03.047. Epub 2021 Mar 29.

    PubMed 33794306

  • Peng H, Moore C, Zhang Y, Saha D, Jiang S, Timmerman R. An AI-based approach for modeling the synergy between radiotherapy and immunotherapy. Sci Rep. 2024 Apr 8;14(1):8250. doi: 10.1038/s41598-024-58684-6.

    PubMed 38589494

  • Rouf S, Moore C, Saha D, Nguyen D, Bleile M, Timmerman R, Peng H, Jiang S. PULSAR Effect: Revealing potential synergies in combined radiation therapy and immunotherapy via differential equations. J Theor Biol. 2025 Jan 7;596:111974. doi: 10.1016/j.jtbi.2024.111974. Epub 2024 Oct 22.

    PubMed 39448025

  • Peng H, Moore C, Saha D, Jiang S, Timmerman R. Understanding the PULSAR effect in combined radiotherapy and immunotherapy using transformer-based attention mechanisms. Front Oncol. 2024 Dec 2;14:1497351. doi: 10.3389/fonc.2024.1497351. eCollection 2024.

    PubMed 39687891

  • Chen B, Yao W, Li X, Lin G, Chu Q, Liu H, Du Y, Lin J, Duan H, Wang H, Xiao Z, Sun H, Liu L, Xu L, Xu Y, Xu F, Kong Y, Pu X, Li K, Wang Q, Li J, Li B, Xia Y, Wu L. A phase Ib/II study of cadonilimab (PD-1/CTLA-4 bispecific antibody) plus anlotinib as first-line treatment in patients with advanced non-small cell lung cancer. Br J Cancer. 2024 Feb;130(3):450-456. doi: 10.1038/s41416-023-02519-0. Epub 2023 Dec 18.

    PubMed 38110665

  • Li J, Zhou S, Xu X, Zheng Q, Zhang F, Luo C, Li D, Sun X, Han Z, Wu W, Yan J, Shao Y, Zhang Y, Wu B, Wei Q, Wang X, Zhou Y, Sun W, Xu Q, Ying J. Sintilimab and anlotinib with gemcitabine plus cisplatin in advanced biliary tract cancer: SAGC a randomized phase 2 trial. Nat Commun. 2025 Jul 1;16(1):5559. doi: 10.1038/s41467-025-60119-3.

    PubMed 40593475

  • Liu L, Chen B, Tang M, Guo Y, Hou J, Zhou W, Zhu X. Combination of anlotinib and toripalimab for an advanced biliary tract cancer patient with high Eastern Cooperative Oncology Group performance status: a case report. Anticancer Drugs. 2024 Sep 1;35(8):752-756. doi: 10.1097/CAD.0000000000001619. Epub 2024 May 10.

    PubMed 38728054

  • Zhou M, Jin Y, Zhu S, Xu C, Li L, Liu B, Shen J. A phase II study to evaluate the safety and efficacy of anlotinib combined with toripalimab for advanced biliary tract cancer. Clin Transl Immunology. 2024 Jan 12;13(1):e1483. doi: 10.1002/cti2.1483. eCollection 2024.

    PubMed 38223257

  • Zhou J, Sun Y, Zhang W, Yuan J, Peng Z, Wang W, Gong J, Yang L, Cao Y, Zhao H, Chen C, Wang W, Shen L, Zhou A. Phase Ib study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis. Hepatology. 2023 Jan 1;77(1):65-76. doi: 10.1002/hep.32548. Epub 2022 Aug 18.

    PubMed 35491432

  • Li D, Chi Y, Chen X, Ge M, Zhang Y, Guo Z, Wang J, Chen J, Zhang J, Cheng Y, Li Z, Liu H, Qin J, Zhu J, Cheng R, Xu Z, Zheng X, Tang P, Gao M. Anlotinib in Locally Advanced or Metastatic Medullary Thyroid Carcinoma: A Randomized, Double-Blind Phase IIB Trial. Clin Cancer Res. 2021 Jul 1;27(13):3567-3575. doi: 10.1158/1078-0432.CCR-20-2950. Epub 2021 Apr 8.

    PubMed 33832949

  • Chi Y, Fang Z, Hong X, Yao Y, Sun P, Wang G, Du F, Sun Y, Wu Q, Qu G, Wang S, Song J, Yu J, Lu Y, Zhu X, Niu X, He Z, Wang J, Yu H, Cai J. Safety and Efficacy of Anlotinib, a Multikinase Angiogenesis Inhibitor, in Patients with Refractory Metastatic Soft-Tissue Sarcoma. Clin Cancer Res. 2018 Nov 1;24(21):5233-5238. doi: 10.1158/1078-0432.CCR-17-3766. Epub 2018 Jun 12.

    PubMed 29895706

  • Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13.

    PubMed 29438373

  • Mie T, Sasaki T, Okamoto T, Furukawa T, Takeda T, Kasuga A, Ozaka M, Sasahira N. Current Status of Targeted Therapy for Biliary Tract Cancer in the Era of Precision Medicine. Cancers (Basel). 2024 Feb 22;16(5):879. doi: 10.3390/cancers16050879.

    PubMed 38473240

  • Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, Falk S, Gillmore R, Wadsley J, Patel K, Anthoney A, Maraveyas A, Iveson T, Waters JS, Hobbs C, Barber S, Ryder WD, Ramage J, Davies LM, Bridgewater JA, Valle JW; Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021 May;22(5):690-701. doi: 10.1016/S1470-2045(21)00027-9. Epub 2021 Mar 30.

    PubMed 33798493

  • Zhang D, Dorman K, Westphalen CB, Haas M, Ormanns S, Neumann J, Seidensticker M, Ricke J, De Toni EN, Klauschen F, Algul H, Reislander T, Boeck S, Heinemann V. Unresectable biliary tract cancer: Current and future systemic therapy. Eur J Cancer. 2024 May;203:114046. doi: 10.1016/j.ejca.2024.114046. Epub 2024 Apr 12.

    PubMed 38626513

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib + Cadonilimab and PULSAR in people with Previously Treated, Advanced and Biliary Tract Cancers, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (RECIST v1.1) (time frame: From the first patient enrollment until 6 months after the last patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07635290, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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