Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patient with Unresectable Pancreatic Cancer
- Conditions
- Patients with stage III or IV unresectable pancreatic cancer.
- Registration Number
- JPRN-jRCT1080223615
- Lead Sponsor
- Takara Bio Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 36
1) Patients with histologically or cytologically confirmed unresectable pancreatic cancer (stage III or IV) based on the General Rules for the Study of Pancreatic Cancer (The 7th edition). Patient(stage III) who never received anti-cancer therapy (radiation therapy, chemotherapy, immunotherapy, surgery, clinical trials) or patient (stage IV) who previously received gemcinabine-base therapy.
2) Patients with primary lesion will be intratumorally injectable for TBI-1401(HF10) by EUS (endoscopic ultrasound).
3) Patients must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment.
4) Patients must have a life expectancy greater than or equal to 12 weeks.
5) Patients must have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0-1.
1) Patients receiving anti-herpes medication within 1 week prior to TBI-1401(HF10) treatment (except local treatment such as ointment).
2) Patients with a significant tumor bleeding or coagulation abnormality that could not treat intratumoral injection or biopsy in safe.
3) Patients receiving other clinical study drugs or products within 4 weeks prior to initiating study treatment.
4) Patients with active CNS metastases.
5) Patients with ascites, except acceptable mild ascites.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>DLT (Dose Limiting Toxicity) <br>Evaluated by NCI-CTCAE ver. 4.0.
- Secondary Outcome Measures
Name Time Method safety<br>Adverse Events (AEs) <br>Evaluated by NCI-CTCAE ver. 4.0.<br>efficacy<br>Objective response rate (ORR) [at 16 weeks and through study completion] <br>Evaluated by RECIST ver.1.1.<br>efficacy<br>1 year survival rate <br>Determine the 1 year survival rate of patient who received treatment.