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SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Prospective, Randomized, Controlled Phase II Study of SHR-1701 in Combination With Stereotactic Body Radiotherapy (SBRT) for Metastatic Castration-Resistant Prostate Cancer

NCT07451795•Fudan University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Age: 18 to 80 years old.
•2. Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the prostate, clinically staged as metastatic prostate cancer based on conventional imaging (bone scan or CT/MRI).
•3. Biopsy: Whenever possible, patients should undergo a pre-treatment image-guided biopsy of a lesion; alternatively, archived biopsy tissue obtained within 30 days prior to enrollment is acceptable.
•4. Prior Therapy: Failure of at least one prior next-generation hormone therapy (NHT), such as abiraterone acetate, rezivilutamide, enzalutamide, apalutamide, or darolutamide.
•5. Chemotherapy History: Prior treatment with docetaxel, or documentation of intolerance to or refusal of chemotherapy.
•6. Disease Progression: Evidence of disease progression defined by: PSA progression: At least two consecutive increases in PSA levels, measured at least 1 week apart, with a screening PSA value ≥ 1 ng/mL; OR Radiographic progression in soft tissue per RECIST v1.1 (with or without PSA progression); OR Bone progression per PCWG3 criteria (occurrence of ≥ 2 new bone lesions on bone scan).
•7. Castration Status: Maintenance of effective and continuous luteinizing hormone-releasing hormone analog (LHRHa) therapy throughout the study period, or prior bilateral orchidectomy; serum testosterone must be maintained at castrate levels (\< 50 ng/dL).
•8. Performance Status: ECOG Performance Status score of 0 to 2.
•9. Life Expectancy: ≥ 6 months.
•10. Hematologic Function: Absolute neutrophil count (ANC) ≥ 1.5 ×10\^9/L; Platelets ≥ 75 ×10\^9/L; Hemoglobin ≥ 90 g/L; White blood cell (WBC) count ≥ 3.0 ×10\^9/L.
+10 more criteria

Exclusion Criteria

•1. Concurrent Therapy: Plan to receive any other anti-tumor therapy during the study treatment period.
•2. Brain Metastasis: Presence of brain metastases.
•3. Prior Immunotherapy: 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.
•4. Other Malignancies: Known other malignancies that are progressing or require active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy.
•5. Autoimmune Disease/Infection: Active autoimmune disease or active infection (including tuberculosis) requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal/pituitary insufficiency) is not considered systemic treatment.
•6. Immunosuppression: Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose.
•7. Pneumonitis: History of (non-infectious) pneumonitis requiring steroid treatment or current non-infectious pneumonitis.
•8. Prior Radiation/Hormonal Washout: Receipt of radiotherapy or radionuclide therapy (e.g., Radium-223) within 28 days prior to the first dose; or abiraterone within 1 week, or other anti-androgen therapy within 2 weeks prior to the first dose.
•9. Hypersensitivity: Hypersensitivity or intolerance to the active ingredients or any excipients of the PD-L1 monoclonal antibody.
•10. Neuropsychiatric Disorders: Known history of significant neurological or psychiatric disorders, such as dementia, epilepsy, or seizure-prone conditions.
+2 more criteria

Locations (3)

Fujian Cancer Hospital

Fujian, China

Fudan University Shanghai Cancer Center

Shanghai, China

Fudan University Shanghai Cancer Center Xiamen Branch

Xiamen, China

Key Dates

Start Date

March 2, 2026

Primary Completion Date

March 31, 2028

Completion Date

December 31, 2028

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Prostate CancermCRPC (Metastatic Castration-resistant Prostate Cancer)

Interventions

SHR-1701 + SBRT

COMBINATION_PRODUCT

SBRT

RADIATION

Contacts

Yao Zhu

CONTACT

13816751347 zhuyao@fudan.edu.cn

XuDong Ni

CONTACT

19946234803 xdni18@fudan.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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