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Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients with Unresectable Pancreatic Cancer.
Sponsor: Takara Bio Inc.
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.
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.
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2017-09-25
Completion Date
2035-03-31
Last Updated
2024-12-09
Healthy Volunteers
No
Interventions
TBI-1401(HF10)
1x10\^6 or 1x10\^7 TCID50/mL TBI-1401(HF10) administered by intratumoral injection at 2-week intervals. Patients may continue to receive the injections for up to 1 year if eligible for injection.
Gemcitabine
1000 mg/m\^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
Nab-paclitaxel
125 mg/m\^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
TS-1
TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest.
Locations (8)
Clinical Site
Nagoya, Aichi-ken, Japan
Clinical Site
Chiba, Chiba, Japan
Clinical Site
Kashiwa, Chiba, Japan
Clinical Site
Yokohama, Kanagawa, Japan
Clinical Site
Osaka, Osaka, Japan
Clinical Site
Chūōku, Tokyo, Japan
Clinical Site
Koto-Ku, Tokyo, Japan
Clinical Site
Nagoya, Japan