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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H101 + Tislelizumab | Experimental | (Dose escalation and cohort expansion) H101 administered by Intraperitoneal injection in combination with Tislelizumab administered intravenously (IV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H101 | Drug | H101 intratumorally injection starts at day 0. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number 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. | 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. | 28 days |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | max 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | max 24 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Wang, MD | Contact | 86-21-64175590 | peng_wang@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Peng Wang, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| Tislelizumab |
| Drug |
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. |
|
ORR according to RECIST 1.1
| max 24 months |
| Duration of Response | max 24 months |
| Progression Free Survival | max 24 months |
| Overall survival | max 42 months |
| disease control rate | 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). | max 24 months |