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Clinical Trials/JPRN-jRCT1080223615
JPRN-jRCT1080223615CompletedPhase 1

Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patient with Unresectable Pancreatic Cancer

Takara Bio Inc.0 sites36 target enrollmentStarted: August 10, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
36
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Investigators

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