Actively Recruiting
PULSAR Radiotherapy Plus Anti-PD-1 Therapy in Metastatic Abdominopelvic Tumors
Led by Zhen Zhang · Updated on 2026-02-03
103
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PULSAR Radiotherapy Plus Anti-PD-1 Therapy in Metastatic Abdominopelvic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of enrollment, any sex
- Confirmed metastatic abdominopelvic cancer of hepatocellular carcinoma, renal cell carcinoma, or urothelial carcinoma
- No more than 10 metastatic lesions with a radiotherapy plan that can be safely delivered
- At least one measurable tumor lesion
- ECOG performance status of 0 to 2
- Determined by multidisciplinary team to need active antitumor treatment
- Adequate bone marrow, liver, kidney, and coagulation function based on lab tests within 7 days before first treatment dose
- No blood transfusion, blood products, G-CSF, or hematopoietic growth factors within 7 days before lab tests
- Voluntary informed consent and willingness to follow study treatment and visit schedule
You will not qualify if you...
- Absolute neutrophil count below 1.5 x 10^9/L, platelet count below 100 x 10^9/L (or below 80 x 10^9/L in liver metastases), or hemoglobin below 9 g/dL
- Blood transfusion within 2 weeks before enrollment to meet eligibility
- Serum total bilirubin over 1.5 times upper normal limit, or over 2.5 times in liver metastases
- AST or ALT over 2.5 times upper normal limit, or over 5 times in liver metastases
- Estimated glomerular filtration rate below 30 mL/min/1.73 m2
- Significant electrolyte abnormalities
- Active gastrointestinal diseases or bleeding risks including ulcers, colitis, or unresected tumor bleeding
- History of gastrointestinal perforation or fistula not fully healed
- Arterial or deep vein thrombosis within 6 months, bleeding tendency within 2 months
- Stroke or transient ischemic attack within 12 months
- Severe cardiac disease within 6 months including heart failure, recent heart attack, unstable angina, coronary bypass, NYHA class II or higher heart failure, or left ventricular ejection fraction below 50%
- Detectable second primary cancer or history of other cancer within 5 years except certain early-stage cancers
- Significant liver disease including active hepatitis B or C or cirrhosis
- Pregnant or breastfeeding women, or unwillingness to use effective contraception
- Any clinical or lab abnormality or compliance issue making participation unsuitable
- Severe psychological or psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jing Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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