CholangiocarcinomaPhase 1/2NCT07291947
PULSAR Combined With Immunotherapy and Chemotherapy
A Phase 1/2 study testing Iparomlimab and Tuvonralimab Injection (QL1706) and PULSAR in people with Cholangiocarcinoma, run by Wang Xin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Iparomlimab and Tuvonralimab Injection (QL1706) and PULSAR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2025to 10 Sep 2027
- Phase
- Phase 1/2
- 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
- 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.
- Age 18-75 years, regardless of gender.
- Histopathologically or cytologically confirmed locally advanced or metastatic cholangiocarcinoma.
- At least one measurable lesion based on RECIST 1.1 criteria.
- ECOG performance status score of 0-1.
- Expected survival time ≥3 months.
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- Willing to comply with study procedures and able to undergo treatment (including radiotherapy, immunotherapy, chemotherapy) and follow-up.
- No contraindications to the use of PD-1, PD-L1 inhibitors, gemcitabine, or cisplatin.
- No contraindications to radiotherapy.
- 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.
- 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.
- Women must be non-lactating.
Who cannot join
- Previously treated with anti-PD-1 or anti-PD-L1 antibodies.
- Received any investigational drug treatment within 4 weeks prior to the first administration of the study drug.
- 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.
- Previously received radiotherapy to the upper abdomen.
- 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.
- 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.
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- 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.
- 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.
- 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.
- History of allergy or hypersensitivity to any component of the treatment.
- 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.
- Previously received systemic therapy for cholangiocarcinoma.
- Positive for hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies.
- Active infection requiring systemic treatment.
- Other conditions deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
shu pei, +86 028 85422654, peishu1991@sina.com
About this study
Official title: Phase I/II Clinical Study of Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy and Chemotherapy in Patients With Cholangiocarcinoma
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 monoclonal antibody + CTLA-4 monoclonal antibody) on the tumor microenvironment and systemic immune responses in cholangiocarcinoma patients.
Read the 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.
- Conditions
- Cholangiocarcinoma
- Being tested
- Iparomlimab and Tuvonralimab Injection (QL1706), PULSAR
- Keywords
- locally advanced or metastatic cholangiocarcinoma, PULSAR, immunotherapy, chemotherapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab Injection (QL1706)Drug
Also called chemotherapy
GC chemotherapy and Iparomlimab and Tuvonralimab Injection
PULSARRadiation
Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| PULSAR Combined with Immunotherapy and Chemotherapy | Experimental | PULSAR Combined with Immunotherapy and Chemotherapy Receives: Drug: Iparomlimab and Tuvonralimab Injection (QL1706); Radiation: PULSAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment
Secondary outcomes (1)
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
Measured: Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start4 Nov 2025
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Xin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Xin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291947
- Sponsor's protocol ID
- PULSAR-ICON
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study of Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy and Chemotherapy in Patients With Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT07291947
- Acronym / sponsor ID
- PULSAR-ICON
- Conditions
- Cholangiocarcinoma
- Keywords
- locally advanced or metastatic cholangiocarcinoma, PULSAR, immunotherapy, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wang XinUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 monoclonal antibody + CTLA-4 monoclonal antibody) on the tumor microenvironment and systemic immune responses in cholangiocarcinoma patients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PULSAR Combined with Immunotherapy and Chemotherapy | Experimental | Drug: Iparomlimab and Tuvonralimab Injection (QL1706), Radiation: PULSARPULSAR Combined with Immunotherapy and Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- Age 18-75 years, regardless of gender.
- Histopathologically or cytologically confirmed locally advanced or metastatic cholangiocarcinoma.
- At least one measurable lesion based on RECIST 1.1 criteria.
- ECOG performance status score of 0-1.
Key exclusion criteria (15 listed)
- Previously treated with anti-PD-1 or anti-PD-L1 antibodies.
- Received any investigational drug treatment within 4 weeks prior to the first administration of the study drug.
- 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.
- Previously received radiotherapy to the upper abdomen.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvonralimab Injection (QL1706)Also: chemotherapyGC chemotherapy and Iparomlimab and Tuvonralimab Injection | Drug | PULSAR Combined with Immunotherapy and Chemotherapy |
| PULSARPersonalized Ultra-fractionated Stereotactic Adaptive Radiotherapy | Radiation | PULSAR Combined with Immunotherapy and Chemotherapy |
Primary outcome
Safety of immunotherapy and chemotherapy combined with PULSAR radiation therapy
Time frame: Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment
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
1 secondary outcome
immunological impact of immunotherapy and chemotherapy combined with PULSAR radiation therapy
Time frame: Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Iparomlimab and Tuvonralimab Injection (QL1706) and PULSAR in people with Cholangiocarcinoma, run by Wang Xin 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 12 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Dr. shu (+ 028 85423609, peishu1991@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of immunotherapy and chemotherapy combined with PULSAR radiation therapy (time frame: Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.