Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites (NCT05303844) | Clinical Trial Compass
UnknownPhase 1
Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites
China25 participantsStarted 2022-04-02
Plain-language summary
The objective of this study is to evaluate the safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab for patients with refractory malignant ascites.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent obtained.
* Age ≥ 18 years at time of study entry.
* Pathologically diagnosed solid tumor malignancy.
* Malignant peritoneal ascites confirmed by peritoneal brush cytology.
* Failures from chemotherapy against malignant ascites.
* Cooperative Oncology Group-Status (ECOG Status) 0 or 1
Exclusion Criteria:
* Previous (\<4 weeks) or concurrent treatment with systemic or intraperitoneal chemotherapy or biological agents such as monoclonal antibodies.
* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
* Prior treatment with oncolytic virotherapy.
* Radiotherapy administered less then 4 weeks prior to study treatment start.
* Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
* Participation in another clinical study with an investigational product during the last 30 day…
What they're measuring
1
Number of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 5.0
Timeframe: 28 days
2
Maximum tolerated dose (MTD) of intratumoral injection of H101 on at three dose levels in combination with anti-PD1 antibody.
Timeframe: 28 days
3
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0