New combo therapy aims to shrink Hard-to-Treat cancers
NCT ID NCT07383857
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
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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
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About 103 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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