prostate cancer
Conditions
Interventions
Test group:Toripalimab combined with Gemcitabine
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology. 2. Evidence of metastatic disease, bone lesions by bone scan and/or soft tissue lesions by CT/MRI. 3. One of the following advances occurred at the start of the study: a) detection of PSA progression based on PCWG3 criteria; b) Soft tissue radiological disease progression according to RECIST V1.1 and c) Bone radiation disease progression based on PCWG3 criteria. 4. Have been previously treated with a new generation of hormone drugs (such as: abiraterone, enzalutamide, apalutamide, dalolutamide), and need to meet one of the following two conditions: a) disease progression after at least 8 weeks of treatment; b) Intolerance to the drug after at least 4 weeks of treatment. 5. ECOG (Eastern Cooperative Oncology Group criteria) score of 0 or 1. 6. Male, aged 45-90 years old (including boundary value). 7. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with systemic anticancer therapy, targeted small molecule therapy, or abiraterone acetate, enzalutamide, apalutamide, daloxamide or 5a reductase inhibitor, estrogen, and/or cyproterone, = 4 weeks after the start of treatment. 2. Known presence of active central nervous system metastases and/or carcinomatous meningitis. 3. Other previous or concurrent malignant tumors. 4. Concurrent with other serious systemic diseases that may interfere with the treatment, evaluation, or compliance of this trial. 5. Participation in any other trials that are ongoing or have been completed within 6 months. 6. Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, illiteracy, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Radiographically progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate-specific antigen (PSA) response rate;Objective response rate;Duration of remission;Time to pain progression;Time to first occurrence of symptomatic bone-related event (SSRE).;Time to prostate-specific antigen (PSA) progression;Time to radiological soft tissue progression;Number of participants with adverse events (AEs).;Number of Participants Who Discontinued Study Treatment Due to Adverse Events (AEs).; | — |
Countries
China
Contacts
Public ContactYicheng Chen
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed