Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites

  • STATUS
    Recruiting
  • End date
    Mar 20, 2025
  • participants needed
    25
  • sponsor
    Fudan University
Updated on 27 April 2022

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.

Description

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.

Details
Condition Refractory Malignant Ascites
Treatment tislelizumab, H101
Clinical Study IdentifierNCT05303844
SponsorFudan University
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer
Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to
history of interstitial lung disease
Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
known acute or chronic pancreatitis
active tuberculosis
any other active infection (viral, fungal or bacterial) requiring systemic therapy
history of allogeneic tissue/solid organ transplant
diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Tislelizumab treatment
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study
Live vaccine within 30 days prior to the first dose of Tislelizumab treatment or during study treatment
History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of Tislelizumab treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS
Medication that is known to interfere with any of the agents applied in the trial
Any other efficacious cancer treatment except protocol specified treatment at study start
Patient has received any other investigational product within 28 days of study entry
Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening
Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent
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