Intratumoral administration of oncolytic virus for unresectable pancreatic cancer

JRCT ID: jRCT2073200004

Registered date:15/04/2020

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 15/04/2020
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Intratumoral administration of oncolytic virus

Outcome(s)

• Primary Outcome: Adverse event, response rate
• Secondary Outcome: Serum level of adenovirus, adenovirus excretion, antibody level of adenovirus, cytokine levels, rate of tumor size reduction, histological assessment, progression-free survival, overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The patients with pancreatic tumors must meet the following eligibility criteria:
1)Diagnosed histologically with pancreatic ductal carcinoma.
2)Diagnosed with unresectable pancreatic cancer because of metastasis and/or vascular invasion.
3)Primary standard treatment for unresectable pancreatic cancer failed.
If a patient who received radiation or chemoradiation therapy for locally advanced pancreatic cancer is judged to have failed the primary treatment due to metastasis without progression of pancreatic cancer or drug-induced adverse events, the period after radiation must be at least one month.
4)The long and short axes and height of the pancreatic lesion can be measured by computed tomography, and the investigational agent can be administered to the lesion.
5)>= 20 years old.
6)ECOG performance status (PS) is 0-2.
7)The overall survival is expected to exceed three months.
8)Main organ functions are maintained (according to the latest blood test performed within two weeks before registration):
Hb >= 7 g/dL
WBC >= 2,000/microL
Plt >= 50,000/microL
AST (GOT) <= 100 IU/L
ALT (GPT) <= 100 IU/L
T-bil <= 3.0 mg/dL
Cr <= 2.0 mg/dL
9)Agrees to not become pregnant.
10)Gives their written consent to participate in the clinical trial.

Exclude criteria

1)Patients with the following complications: Severe heart disease, severe respiratory disease, severe digestive disease, severe liver disease, uncontrolled diabetes, and infection requiring continuous treatment
2)Patients with a history of penicillin or allergy to pigs or cattle (including milk).
3)Patients with a disease that requires the administration of systemic immunosuppressants or steroids.
4)For patients judged to have failed the primary therapy of radiation or chemoradiation, the interval after the therapy is <= 1 month (patients are still eligible if the reason for primary therapy failure is progression of pancreatic cancer).
5)Patients with other currently active cancers (patients are still eligible if the other cancers are basal cell carcinoma, carcinoma in situ, superficial bladder cancer, or malignancies without metastasis or recurrence for more than five years and have been treated appropriately)
6)Patients with an uncontrollable fever or pain due to the tumor.
7)Patients with a history of gastroduodenal surgery or gastroduodenal stricture.
8)Patients who are pregnant, breast-feeding, or have a positive pregnancy test within one year after menopause.
9)Patients who received any other unapproved drug within four weeks before giving their consent.
10)Patients deemed inappropriate to include in the trial by the investigator.

Related Information

• Primary Sponsor: Ido Akio
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000039854