SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorFudan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age: 18 to 80 years old.
Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the prostate, clinically staged as metastatic prostate cancer based on conventional imaging (bone scan or CT/MRI).
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.
Prior Therapy: Failure of at least one prior next-generation hormone therapy (NHT), such as abiraterone acetate, rezivilutamide, enzalutamide, apalutamide, or darolutamide.
Disqualifiers
Concurrent Therapy: Plan to receive any other anti-tumor therapy during the study treatment period.
Brain Metastasis: Presence of brain metastases.
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
SHR-1701 + SBRT
Combination productStereotactic body radiotherapy on targeted metastasis determined by MDT + SHR1701 30mg/kg IV every 3 weeks (Q3W) for 2 cycles, then SHR1701 alone Q3W until progression
SBRT
RadiationStereotactic body radiotherapy on targeted metastasis determined by MDT
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Radiotherapy plus immunotherapy groupExperimental treatment 1 intervention
Group B: Radiotherapy alone groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic Progression-Free Survival (rPFS)
Description: Defined as bone disease progression (occurrence of two or more new lesions on bone scan) per PCWG3, or soft tissue/clinical progression per RECIST v1.1.
Time frame
From randomization to radiographic progression or death (up to 24 months)Secondary outcomes
1
Objective Response Rate (ORR)
The proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), as assessed by RECIST v1.1 and PCWG3 criteria.
Time frame
From randomization until progression (up to 24 months)2
PSA Response Rate
The proportion of patients achieving a ≥ 50% reduction in serum PSA from baseline, confirmed by a second measurement at least 3 weeks later.
Time frame
From randomization until progression (up to 24 months)3
PSA Progression-Free Survival (PSA-PFS)
Defined according to PCWG3 criteria as: (1) For patients with a decline from baseline: A ≥ 25% increase in PSA and an absolute increase of ≥ 2 ng/mL above the nadir, confirmed by a second measurement at least 3 weeks later; (2) For patients without a decline from baseline: A ≥ 25% increase in PSA and an absolute increase of ≥ 2 ng/mL from baseline after at least 12 weeks of intervention. Subjects with PSA progression alone in the absence of symptomatic or radiographic progression may continue treatment at the investigator's discretion if clinical benefit is perceived.
Time frame
From randomization until progression (up to 24 months)4
Overall Survival (OS)
Defined as the time from enrollment to death from any cause.
Time frame
From randomization until death (up to 24 months)Other outcomes
1
Immune Microenvironment Analysis
Evaluation of the immune microenvironment in peripheral blood and tumor lesions
Time frame
up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov