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Clinical Trial NCT07291947 for Cholangiocarcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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PULSAR Combined With Immunotherapy and Chemotherapy Phase 1, Phase 2 60 Immunotherapy Monoclonal Antibody

Recruiting
Clinical Trial NCT07291947 is designed to study Treatment for Cholangiocarcinoma. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 4 November 2025, with plans to enroll 60 participants. Led by Wang Xin, it is expected to complete by 10 September 2027. The latest data from ClinicalTrials.gov was last updated on 18 December 2025.
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety of PULSAR in combination with dual immune checkpoint inhibitors (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) and GC chemotherapy in patients with locally advanced or metastatic cholangiocarcinoma. The secondary objective of this study is to investigate the immunological impact of PULSAR combined with dual immune therapy (PD-1 monocl...Show More
Detailed Description
After confirmation of eligibility, enrolled patients will undergo radiation CT simulation and planning per standard of care. IV contrast will be administered with CT simulation at the treating physician's discretion though is not required.
Official Title

Phase I/II Clinical Study of Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy and Chemotherapy in Patients With Cholangiocarcinoma

Conditions
Cholangiocarcinoma
Other Study IDs
  • PULSAR-ICON
NCT ID Number
NCT07291947
Start Date (Actual)
2025-11-04
Last Update Posted
2025-12-18
Completion Date (Estimated)
2027-09-10
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Recruiting
Keywords
locally advanced or metastatic cholangiocarcinoma
PULSAR
immunotherapy
chemotherapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPULSAR Combined with Immunotherapy and Chemotherapy
PULSAR Combined with Immunotherapy and Chemotherapy
Iparomlimab and Tuvonralimab Injection (QL1706)
GC chemotherapy and Iparomlimab and Tuvonralimab Injection
PULSAR
Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Safety of immunotherapy and chemotherapy combined with PULSAR radiation therapy
Evaluation of reported adverse events (AEs) and serious adverse events (SAEs), according to CTCAE v5.0. Evaluation of changes from Baseline during the Treatment and Follow-up periods
Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
immunological impact of immunotherapy and chemotherapy combined with PULSAR radiation therapy
Evaluation of immunological impact of PULSAR combined with dual immune therapy (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) on the tumor microenvironment and systemic immune responses in cholangiocarcinoma patients according to flow cytometry. Evaluation of changes from Baseline during the Treatment and Follow-up periodsTo investigate the
Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Signed informed consent. The subject has fully understood and accepted the purpose, content, expected efficacy, mechanism of action, and risks of the study, and has signed the informed consent form.
  2. Age 18-75 years, regardless of gender.
  3. Histopathologically or cytologically confirmed locally advanced or metastatic cholangiocarcinoma.
  4. At least one measurable lesion based on RECIST 1.1 criteria.
  5. ECOG performance status score of 0-1.
  6. Expected survival time ≥3 months.
  7. Willing to comply with study procedures and able to undergo treatment (including radiotherapy, immunotherapy, chemotherapy) and follow-up.
  8. No contraindications to the use of PD-1, PD-L1 inhibitors, gemcitabine, or cisplatin.
  9. No contraindications to radiotherapy.
  10. Organ function levels meet the following requirements: - Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; - Platelet (PLT) count ≥ 80 × 10⁹/L; - Hemoglobin (Hb) level ≥ 90 g/L; - Total bilirubin (TBil) level ≤ 1.5 times the upper limit of normal (ULN); - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; if liver metastases are present, ≤ 5 times ULN; - Serum creatinine ≤ 1.5 times ULN, or calculated creatinine clearance rate ≥ 50 ml/min; - International normalized ratio (INR) ≤ 1.5 times ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, unless the subject is receiving anticoagulant therapy. - Hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≤ 1 × 10³ copies/L; if HBsAg positive and peripheral blood HBV-DNA titer ≥ 1 × 10³ copies/L, subjects may be included if the investigator determines that the chronic hepatitis B is stable and poses no additional risk.
  11. Women of childbearing potential must agree to use appropriate contraceptive measures during the study period. Additionally, a serum or urine pregnancy test performed within 24 hours prior to the initiation of chemotherapy must be negative.
  12. Women must be non-lactating.

  1. Previously treated with anti-PD-1 or anti-PD-L1 antibodies.
  2. Received any investigational drug treatment within 4 weeks prior to the first administration of the study drug.
  3. Simultaneous participation in other clinical studies, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional clinical study.
  4. Previously received radiotherapy to the upper abdomen.
  5. Uncontrolled severe diseases that the investigator considers may affect the subject's ability to receive study protocol treatment, such as severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infections, active peptic ulcers, etc.
  6. Active known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator treatment). Patients with hypothyroidism requiring hormone replacement therapy and those with skin conditions not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia) may be included.
  7. Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within the past year will be excluded, even if treated. Patients with a history of active pulmonary tuberculosis infection more than one year ago will also be excluded unless evidence is provided that they have undergone standard anti-tuberculosis treatment.
  8. Patients requiring long-term systemic corticosteroid therapy (equivalent to >10 mg prednisone/day) or any other form of immunosuppressive therapy. Patients using inhaled or topical corticosteroids may be included.
  9. Uncontrolled cardiac disease, such as: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within the past year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. Additionally, dementia, altered mental status, or any psychiatric disorders that could impair the ability to understand, provide informed consent, or complete questionnaires.
  10. History of allergy or hypersensitivity to any component of the treatment.
  11. History of malignant tumors within the past 5 years, except for completely treated basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after radical surgery.
  12. Previously received systemic therapy for cholangiocarcinoma.
  13. Positive for hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies.
  14. Active infection requiring systemic treatment.
  15. Other conditions deemed unsuitable for inclusion by the investigator.
Wang Xin logoWang Xin
Study Responsible Party
Wang Xin, Sponsor-Investigator, Clinical Professor, West China Hospital
Study Central Contact
Contact: Dr. shu, + 028 85423609, [email protected]
1 Study Locations in 1 Countries

Sichuan

West China Hospital, Chengdu, Sichuan, 610041, China
shu pei, Contact, +86 028 85422654, [email protected]
Recruiting