The effect and safety of intraperitoneal infusion of PD-1 inhibitor is unclear for patients with peritoneal metastasis of advanced malignant tumors and malignant ascites. It is planned to determine the safety and efficacy of intraperitoneal infusion of PD-1 inhibitor combination with PRaG therapy.
Patinets with peritoneal metastasis have limited treatment and poor prognosis. Evidence has shown that there are T lymphocates and macrophages in the ascites microenviroment.We suggested the Intraperitoneal infusion of PD-1 inhibitor might activate T cells and produce anti-tumor effect.The intraperitoneal infusion of PD-1 inhibitorand combined with PRaG(Intravenous injectionof PD-1 inhibitor, Radiotherapy and GM-CSF)might benefit the survival of patients with peritoneal metastasis of advanced malignant tumors with malignant ascites. It is planned to determine the safety in phase I clinical trial. Further through phase II clinical trials, to clarify the effectiveness of this therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PD-1 inhibitor (HLX10, serplulimab) 100mg intraperitoneal infusion every two weeks after radiotherapy PD-1 inhibitor (HLX10, serplulimab) 3mg/kg intravenous infusion within one week after radiotherapy every two weeks
200ug qd subcutaneous injection for 7 days
8Gy\*3f
Dose-limiting toxicity(DLT)by CTCAE5.0
CTCAE is widely accepted throughout the oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings
Time frame: 6 months (phase 1)
Treatment Related Severe Adverse Effects
Number of participants with treatment-related severe adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: 6 months (phase 1)
OS
overall survival time
Time frame: 12 months (phase 2)
OS
overall survival time
Time frame: 12 months (phase 1)
PFS
progression-free survival
Time frame: 12 months (phase 1/2)
ascites control rate
ascites control rate
Time frame: 12 months(phase 1/2 )
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