Actively Recruiting
SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC
Led by Fudan University · Updated on 2026-04-30
66
Participants Needed
3
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the efficacy of SHR-1701 in combination with SBRT in patients with metastatic castration-resistant prostate cancer. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study.
CONDITIONS
Official Title
SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Histologically or cytologically confirmed adenocarcinoma of the prostate, clinically staged as metastatic prostate cancer
- Pre-treatment image-guided biopsy of a lesion or archived biopsy tissue within 30 days before enrollment
- Failure of at least one prior next-generation hormone therapy such as abiraterone acetate, rezivilutamide, enzalutamide, apalutamide, or darolutamide
- Prior treatment with docetaxel or documented intolerance/refusal of chemotherapy
- Evidence of disease progression by PSA, radiographic soft tissue progression per RECIST v1.1, or bone progression per PCWG3 criteria
- Maintenance of continuous luteinizing hormone-releasing hormone analog therapy or prior bilateral orchidectomy with castrate serum testosterone levels (< 50 ng/dL)
- ECOG Performance Status score of 0 to 2
- Life expectancy of at least 6 months
- Adequate hematologic function including ANC ≥ 1.5 ×10⁹/L, platelets ≥ 75 ×10⁹/L, hemoglobin ≥ 90 g/L, WBC ≥ 3.0 ×10⁹/L
- Liver enzymes ALT or AST ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases present)
- Total bilirubin ≤ 1.5 × ULN or > 1.5 × ULN if direct bilirubin ≤ ULN
- Coagulation parameters within specified limits including INR ≤ 1.5, APTT ≤ 1.5 × ULN, PT < ULN + 4 seconds
- Cardiac function with LVEF ≥ 50%, QTc < 450 ms for males, serum potassium ≥ 3.5 mmol/L
- Blood pressure controlled with systolic < 160 mmHg and diastolic < 95 mmHg
- Renal function with serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min
- Sexually active patients with ejaculatory potential agree to use effective contraception and refrain from sperm donation from first dose until 3 months after last dose
- Ability to understand and sign informed consent
- Ability to comply with study visit schedule and protocol requirements
You will not qualify if you...
- Planned receipt of any other anti-tumor therapy during the study treatment period
- Presence of brain metastases
- Prior treatment with immune checkpoint inhibitors or agents targeting T-cells or activating the immune system
- Other progressing malignancies or those requiring active treatment within past 3 years, except certain skin cancers or carcinoma in situ treated curatively
- Active autoimmune disease or infection requiring systemic treatment within past 2 years
- Diagnosis of immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 14 days prior to first dose
- History of non-infectious pneumonitis requiring steroids or current non-infectious pneumonitis
- Receipt of radiotherapy or radionuclide therapy within 28 days prior to first dose; or abiraterone within 1 week; or other anti-androgen therapy within 2 weeks prior to first dose
- Hypersensitivity or intolerance to PD-L1 monoclonal antibody components
- Significant neurological or psychiatric disorders such as dementia, epilepsy, or seizure-prone conditions
- Any concurrent severe medical or psychiatric condition posing safety risk or interfering with study completion
- Any unstable medical or psychiatric condition or social/geographical issues affecting compliance or follow-up
- Any other reason investigator deems patient unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Fujian Cancer Hospital
Fujian, China
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
3
Fudan University Shanghai Cancer Center Xiamen Branch
Xiamen, China
Actively Recruiting
Research Team
Y
Yao Zhu
CONTACT
X
XuDong Ni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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