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New combo therapy aims to shrink Hard-to-Treat cancers

NCT ID NCT07383857

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study combines a special type of radiation (PULSAR) with immunotherapy drugs to treat metastatic cancers in the abdomen and pelvis, including liver, kidney, and bladder cancers. About 103 participants will receive the treatment to see if it is safe and helps control the disease. The goal is to improve progression-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pulsed radiotherapy (PULSAR) and PD-1 inhibitor
What this could lead to
If successful, this combination could offer a new way to control metastatic cancers in the abdomen and pelvis, potentially extending survival.
What could go wrong
This is an early-phase study with no control group, so results are uncertain. Side effects from radiation and immunotherapy may be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 103 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years at the time of enrollment, with no restriction on sex. 2. Histologically, cytologically, or radiologically confirmed metastatic abdominopelvic malignancy, including hepatocellular carcinoma, renal cell carcinoma, or urothelial carcinoma. 3. No more than 10 metastatic lesions, and the radiotherapy treatment plan indicates that radiotherapy can be safely delivered. 4. At least one measurable lesion is present. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Determined by a multidisciplinary team (MDT) to require active antitumor treatment. 7. 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. 8. Voluntary participation with written informed consent provided, and willingness to comply with the study treatment protocol and scheduled visits. Exclusion Criteria: 1. 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. 2. Serum total bilirubin \>1.5 × the upper limit of normal (ULN), or \>2.5 × ULN in patients with liver metastases. 3. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 × ULN, or \>5 × ULN in patients with liver metastases. 4. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m². 5. Clinically significant electrolyte abnormalities as determined by the investigator. 6. 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. 7. 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. 8. Stroke or transient ischemic attack within 12 months prior to enrollment. 9. 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%. 10. 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. 11. 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. 12. 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. 13. Any clinical or laboratory abnormality or compliance issue that, in the investigator's judgment, makes the participant unsuitable for participation in this study. 14. Presence of severe psychological or psychiatric disorders.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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