Spots Global Cancer Trial Database for Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients With Unresectable Pancreatic Cancer.

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Trial Identification

Brief Title: Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients With Unresectable Pancreatic Cancer.

Official Title: Phase I Study of Combination With TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Chemotherapy in Patients With Stage III or IV Unresectable Pancreatic Cancer.

Study ID: NCT03252808

Conditions

Pancreatic Cancer Stage III

Pancreatic Cancer Stage IV

Interventions

Study Description

Brief Summary: The purpose of this study is to determine the recommended dose of TBI-1401(HF10) treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in patients with stage III or IV unresectable pancreatic cancer.

Detailed Description: A Phase I, open-label, multi-center study to determine the recommended dose of TBI-1401(HF10) treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in patients with stage III or IV unresectable pancreatic cancer. Patients with stage IV must failed a gemcitabine based first-line chemotherapy. Patients with stage III will receive the repeated intratumoral injection of TBI-1401(HF10) at recommended dose at 2-week intervals in combination with intravenous infusion of 1000 mg/m\^2 Gemcitabine and 125 mg/m\^2 Nab-paclitaxel at weekly for 3 weeks followed by 1 week rest. Patients with stage IV will receive the repeated intratumoral injection of TBI-1401(HF10) at recommended dose at 2-week intervals in combination with oral of 40 - 60 mg TS-1 at twice daily for 4 weeks followed by 2 weeks rest. Patients will receive the combination therapy of TBI-1401(HF10) + chemo for up to 1 year if eligible for treatment.