The objective of this study is to evaluate the safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab for patients with refractory malignant ascites.
This study is to evaluate the safety, effectiveness of local immune activation, and efficiency in patients with refractory malignant ascites after Intraperitoneal injection of oncolytic Viruses H101 and Tislelizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
H101 intratumorally injection starts at day 0.
Tislelizumab will be initiated on day 1. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGNumber of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 5.0
The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: 28 days
Maximum tolerated dose (MTD) of intratumoral injection of H101 on at three dose levels in combination with anti-PD1 antibody.
A MTD is determined if any cohort experiences 2 subjects with DLT's.
Time frame: 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: max 24 months
Ascites Objective Response Rate
The ascites objective response rate (ORR) was calculated as a summed ratio of patients with disappeared and decreased ascites to the total number of patients.
Time frame: max 24 months
Objective Response Rate (ORR)
ORR according to RECIST 1.1
Time frame: max 24 months
Duration of Response
Time frame: max 24 months
Progression Free Survival
Time frame: max 24 months
Overall survival
Time frame: max 42 months
disease control rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: max 24 months
Change from baseline local immune effects after H101 intraperitoneal injections
Detection of increased local immune activation in malignant ascites will be assessed by single cell sequencing and/or Mass Cytometry (CyTOF).
Time frame: max 24 months