OncoMatch/Clinical Trials/NCT07451795
SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC
Is NCT07451795 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies SHR-1701 + SBRT for prostate cancer.
Treatment: SHR-1701 + SBRT — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IV
Metastatic disease required
clinically staged as metastatic prostate cancer based on conventional imaging (bone scan or CT/MRI)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: next-generation hormone therapy (abiraterone acetate, rezivilutamide, enzalutamide, apalutamide, darolutamide)
Failure of at least one prior next-generation hormone therapy (NHT), such as abiraterone acetate, rezivilutamide, enzalutamide, apalutamide, or darolutamide.
Must have received: chemotherapy (docetaxel)
Prior treatment with docetaxel, or documentation of intolerance to or refusal of chemotherapy.
Cannot have received: immune checkpoint inhibitor
Previous treatment with immune checkpoint inhibitors (including PD-1, PD-L1, CTLA-4 inhibitors, etc.) or any anti-tumor agents targeting T-cells or activating the immune system.
Cannot have received: radiation therapy
Receipt of radiotherapy or radionuclide therapy (e.g., Radium-223) within 28 days prior to the first dose
Cannot have received: abiraterone (abiraterone)
abiraterone within 1 week prior to the first dose
Cannot have received: anti-androgen therapy
other anti-androgen therapy within 2 weeks prior to the first dose
Lab requirements
Blood counts
ANC ≥ 1.5 ×10^9/L; Platelets ≥ 75 ×10^9/L; Hemoglobin ≥ 90 g/L; WBC ≥ 3.0 ×10^9/L.
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min.
Liver function
ALT or AST ≤ 2.5 × ULN; for patients with liver metastases, ALT/AST ≤ 5 × ULN. Total bilirubin ≤ 1.5 × ULN, or total bilirubin > 1.5 × ULN if direct bilirubin ≤ ULN.
Cardiac function
LVEF ≥ 50%; QTc < 450 ms for males; serum potassium ≥ 3.5 mmol/L.
Hematologic Function: ANC ≥ 1.5 ×10^9/L; Platelets ≥ 75 ×10^9/L; Hemoglobin ≥ 90 g/L; WBC ≥ 3.0 ×10^9/L. Hepatic Function (Transaminases): ALT or AST ≤ 2.5 × ULN; for patients with liver metastases, ALT/AST ≤ 5 × ULN. Hepatic Function (Bilirubin): Total bilirubin ≤ 1.5 × ULN, or total bilirubin > 1.5 × ULN if direct bilirubin ≤ ULN. Cardiac Function: LVEF ≥ 50%; QTc < 450 ms for males; serum potassium ≥ 3.5 mmol/L. Renal Function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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