Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites

NCT04771676 | Completed Phase 2

• 1 other identifier: 2012229-11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of effectiveness, safety and local immune activation of Oncolytic Viruses H101 in patients with refractory malignant ascites.

Conditions

Refractory Malignant Ascites

Outcome Measures

Primary Outcomes (1)

• Time to repeat paracentesis (TTRP)

  Defined as the number of days between the first paracentesis (baseline) and the subsequent repeat paracentesis.

  max 6 months

Secondary Outcomes (5)

• Analysis of adverse events

  max 6 months

• Paracentesis free survival (PaFS)

  max 6 months

• 60-day frequency of paracentesis

  max 6 months

• Overall survival (OS)

  max 6 months

• Change from baseline local and systemic immune effects after H101 intraperitoneal injections

  at baseline, 3-, 7, 14 days after injection

Study Arms (1)

Oncorine (H101)

EXPERIMENTAL

H101 diluted in 5ml 0.9% sodium chloride solution will be intraperitoneally injected through the drainage catheter. Each patient will receive a dose of 1.5×10\^12 vp by i.p. administration on day 1 and 3.

Drug: Oncorine (H101)

Interventions

Oncorine (H101) DRUG

A modified human recombinant type 5 adenovirus with genetic modifications.

Oncorine (H101)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained.
• Age ≥ 18 years at time of study entry.
• Histologically diagnosed solid tumor malignancy.
• Malignant peritoneal ascites confirmed by cytologic examination.
• Failures from chemotherapy or other anti-cancer therapy or standard chemotherapy was no longer feasible.
• Cooperative Oncology Group-Status (ECOG Status) ≤ 2.
• life expectancy \>8 weeks
• Estimated ascites volume \>1 L by CT scan.
• At least one symptomatic paracentesis within 4 weeks as well as an objectively verified, clinical need for a second paracentesis
• Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/uL, platelets ≥60 x103u/L; Total bilirubin ≤ 3 x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula).
• Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

You may not qualify if:

• History or evidence of active autoimmune disease that requires systemic treatment.
• Acute or chronic active Hepatitis B or C infection or HIV infection.
• Previous (\<4 weeks) or concurrent treatment with systemic or intraperitoneal chemotherapy or biological agents such as monoclonal antibodies.
• Concurrent severe illness such as active infection.
• Enteral feeding at study entry.
• Ileus within the previous 30 days
• \>70% tumor infiltration of the liver or portal vein obstruction.
• Arterial or venous thromboembolic disease.
• 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:
• Known acute or chronic pancreatitis
• Active tuberculosis
• Any other active infection (viral, fungal or bacterial) requiring systemic therapy
• 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.
• History or clinical evidence of Central Nervous System (CNS) metastases. Exceptions for subjects who have completed local therapy. 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Study Officials

• Peng Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: March 5, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (1)