PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites

Sponsor
Second Affiliated Hospital of Soochow University
Study ID
NCT05501340
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Malignant Ascites

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    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
  • Molgramostim — DRUG
    200ug qd subcutaneous injection for 7 days
  • Hypofractionated radiotherapy/Sterotactic body radiotherapy — RADIATION
    8Gy\*3f

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Aug 2022
Primary completion
Dec 31, 2022
Completion
Sep 1, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PRaG combined PD-1 inhibitor intraperitoneal injection
    PRaG(PD-1 inhibitor,Radiotherapy and GM-CSF) combined with PD-1 inhibitor intraperitoneal injection

Primary Outcome Measure

Dose-limiting toxicity（DLT）by CTCAE5.0 [ Time Frame: 6 months (phase 1) ]

Central Contacts

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