NCT03252808Active, not recruitingPhase 1
Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients with Unresectable Pancreatic Cancer.
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.
Source: ClinicalTrials.gov · Last updated 9 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 9 Aug 2017
- Start date
- 25 Sept 2017
- Primary completion date
- 19 Feb 2020
- Lead sponsor
- Takara Bio Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT03252808
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 25 Sept 2017 to the primary completion date, 19 Feb 2020
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving anti-herpes medication within 1 week prior to TBI-1401(HF10) treatment (except local treatment such as ointment).
Other illness
- Patients with a significant tumor bleeding or coagulation abnormality that could not treat intratumoral injection or biopsy in safe.
- Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive and HSV-RNA positive, Human Immunodeficiency Virus (HIV) antibody positive.
- Patients with the active symptom of Epstein-Barr virus (EBV) infection.
- Patients with multiple cancer.
- Patients has a history of allergy for CT contrast agent, live vaccine, any drug excipients, Nab-paclitaxel, Gemcitabine, or any study drugs.
Other
- Patients with active CNS metastases.
- Patients with ascites, except acceptable mild ascites.
- Patients need to treat anticoagulant or antiplatelet agent.
Who the study is looking for
- 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), and never received anti-cancer therapy (radiation therapy, chemotherapy, immunotherapy, surgery, clinical trials).
- Patients with primary lesion will be intratumorally injectable for TBI-1401(HF10) by EUS (endoscopic ultrasound).
- Patients must be ≧20 years of age.
- Patients must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment.
- Patients must have a life expectancy ≧12 weeks.
- Patients must have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0-1.
- Patients demonstrated adequate organ function (≦7 days prior to treatment).
- Females of childbearing potential must have a negative urine or serum pregnancy test within 1 week prior to start of treatment.
- Patients must be able to understand the study and willing to sign a written informed consent document.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Site Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Koto-Ku | Japan | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.