CancerNCT07383857
PULSAR Radiotherapy Plus Anti-PD-1 Therapy in Metastatic Abdominopelvic Tumors
A study testing pulsed radiotherapy in people with Cancer, run by Zhen Zhang at 1 site in China.
Trial summary
This study evaluates hypofractionated radiotherapy combined with PD-1 inhibitor-based systemic therapy in patients with metastatic solid tumors. Eligible patients will be enrolled into three cohorts according to tumor type: metastatic hepatocellular carcinoma, metastatic renal cell carcinoma, and metastatic urothelial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- pulsed radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of enrollment, with no restriction on sex.
- Histologically, cytologically, or radiologically confirmed metastatic abdominopelvic malignancy, including hepatocellular carcinoma, renal cell carcinoma, or urothelial carcinoma.
- No more than 10 metastatic lesions, and the radiotherapy treatment plan indicates that radiotherapy can be safely delivered.
- At least one measurable lesion is present.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Determined by a multidisciplinary team (MDT) to require active antitumor treatment.
- Adequate bone marrow, liver, renal, and coagulation function as demonstrated by laboratory tests performed within 7 days prior to the first dose of study treatment; no blood transfusion, blood products, granulocyte colony-stimulating factor (G-CSF), or other hematopoietic growth factors are permitted within 7 days prior to laboratory testing.
- Voluntary participation with written informed consent provided, and willingness to comply with the study treatment protocol and scheduled visits.
Who cannot join
- Absolute neutrophil count (ANC) <1.5 × 10⁹/L, or platelet count <100 × 10⁹/L (or <80 × 10⁹/L in patients with liver metastases), or hemoglobin <9 g/dL; blood transfusion within 2 weeks prior to enrollment to meet eligibility criteria is not permitted.
- Serum total bilirubin >1.5 × the upper limit of normal (ULN), or >2.5 × ULN in patients with liver metastases.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 × ULN, or >5 × ULN in patients with liver metastases.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Clinically significant electrolyte abnormalities as determined by the investigator.
- Active gastrointestinal diseases, including but not limited to gastric or duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors; or other conditions judged by the investigator to carry a risk of gastrointestinal bleeding or perforation; or a history of gastrointestinal perforation or fistula that has not fully healed after surgical treatment.
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- History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, or evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of severity.
- Stroke or transient ischemic attack within 12 months prior to enrollment.
- Significant cardiac disease within 6 months prior to enrollment, including congestive heart failure, acute myocardial infarction, severe or unstable angina, or coronary artery bypass grafting; or New York Heart Association (NYHA) class II or higher heart failure; or left ventricular ejection fraction (LVEF) <50%.
- Presence of a clinically detectable second primary malignancy at screening, or a history of another malignancy within the past 5 years, except for adequately treated early-stage non-melanoma skin cancer, carcinoma in situ of the cervix, superficial bladder cancer (non-muscle-invasive tumors, carcinoma in situ, or T1 tumors), or early-stage thyroid cancer.
- Known clinically significant liver disease, including but not limited to hepatitis B virus (HBV) infection with positive HBV DNA (≥1 × 10⁴ IU/mL), hepatitis C virus (HCV) infection with positive HCV RNA (≥1 × 10³ IU/mL), or cirrhosis.
- Pregnant or breastfeeding women, women of childbearing potential with a positive pregnancy test prior to first dosing, or participants (or their partners) unwilling to use effective contraception during the study period.
- Any clinical or laboratory abnormality or compliance issue that, in the investigator's judgment, makes the participant unsuitable for participation in this study.
- Presence of severe psychological or psychiatric disorders.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhen Zhang, MD, PhD, 18801735029, zhen_zhang@fudan.edu.cn
About this study
This study evaluates hypofractionated radiotherapy combined with PD-1 inhibitor-based systemic therapy in patients with metastatic solid tumors. Eligible patients will be enrolled into three cohorts according to tumor type: metastatic hepatocellular carcinoma, metastatic renal cell carcinoma, and metastatic urothelial carcinoma. The study aims to assess the safety and therapeutic efficacy of combining localized radiotherapy with immunotherapy, with or without cohort-specific systemic agents.
- Conditions
- Cancer
- Being tested
- pulsed radiotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed radiotherapyRadiation
All enrolled participants will receive pulsed radiotherapy (PULSAR)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Radiation: pulsed radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383857
- Sponsor's protocol ID
- 2502314-15
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PULSAR Radiotherapy Plus Anti-PD-1 Therapy in Metastatic Abdominopelvic Tumors
- ClinicalTrials.gov ID
- NCT07383857
- Acronym / sponsor ID
- 2502314-15
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Zhen ZhangUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 3 Feb 2026 (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.
This study evaluates hypofractionated radiotherapy combined with PD-1 inhibitor-based systemic therapy in patients with metastatic solid tumors. Eligible patients will be enrolled into three cohorts according to tumor type: metastatic hepatocellular carcinoma, metastatic renal cell carcinoma, and metastatic urothelial carcinoma. The study aims to assess the safety and therapeutic efficacy of combining localized radiotherapy with immunotherapy, with or without cohort-specific systemic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: pulsed radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years at the time of enrollment, with no restriction on sex.
- Histologically, cytologically, or radiologically confirmed metastatic abdominopelvic malignancy, including hepatocellular carcinoma, renal cell carcinoma, or urothelial carcinoma.
- No more than 10 metastatic lesions, and the radiotherapy treatment plan indicates that radiotherapy can be safely delivered.
- At least one measurable lesion is present.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (14 listed)
- Absolute neutrophil count (ANC) <1.5 × 10⁹/L, or platelet count <100 × 10⁹/L (or <80 × 10⁹/L in patients with liver metastases), or hemoglobin <9 g/dL; blood transfusion within 2 weeks prior to enrollment to meet eligibility criteria is not permitted.
- Serum total bilirubin >1.5 × the upper limit of normal (ULN), or >2.5 × ULN in patients with liver metastases.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 × ULN, or >5 × ULN in patients with liver metastases.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Clinically significant electrolyte abnormalities as determined by the investigator.
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 |
|---|---|---|
| pulsed radiotherapyAll enrolled participants will receive pulsed radiotherapy (PULSAR) | Radiation | Experimental group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 1 year
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 3 Feb 2026.
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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 study testing pulsed radiotherapy in people with Cancer, run by Zhen Zhang 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 8 inclusion and 14 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 3 Feb 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.
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 Jing Zhang (18801928318, 10301010083@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 1 year). 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 3 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.