OncoMatch/Clinical Trials/NCT07451795
SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC
Is NCT07451795 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07451795 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor, radiation therapy, abiraterone disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 80 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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