- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02650427
A Pilot Study to Evaluate the Safety of a 3 Weeks Sitagliptin Treatment in HCC Patients Undergoing Liver Resection (HCC-DPPIV)
Study Overview
Detailed Description
The study will be conducted in 15 patients. Patient selection will be made based on medical records during a weekly staff meeting. After collection of informed consent, the patients will undergo a biopsy of the tumor and of the not-tumoral liver and 2-4 weeks later HCC resection.
The study will include a phase of 3 weeks [± 7 days] administration of sitagliptin as monotherapy (taken orally) after liver biopsy and before HCC resection. The window of ± 7 days is deliberately wide to take in account the variable arrangements made for surgical resection. Nevertheless we will make our efforts to focus on a three weeks regimen. Three doses of sitagliptin will be used: 1) 100mg/day (dose recommended in the SmCP), 2) 200mg/day and 3) 600mg/day; with 5 patients in each group. Arrangements will be made for surgical resection upon standard care. Blood samples will be obtained for immunology studies at each visit. The study will end one week after surgery (or less if the state of health of the patient does not require to stay longer in the hospital). Patients will continue their treatment for HCC as prescribed by the clinician.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Paris, France, 75013
- Pitie-Salpêtrière Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with 18 years old the day of inclusion.
- For women, a negative blood pregnancy test before inclusion is necessary. Note: this test will be done only to women of childbearing age and non menopausal.
- HCC based on medical imaging with indication of liver resection and without contra-indication of preoperative liver biopsy.
- Minor resection not exceeding 2 liver segments
- No cirrhosis or cirrhosis with a Child-Pugh Score Class A. Note: this score is used worldwide to assess liver function in cirrhosis.
- Informed consent must be obtained for all subjects prior to study entry.
- Patients affiliated to health policy insurance.
Exclusion Criteria:
- Presence of HIV Infection.
- Presence of renal impairment (CrCl <60 ml / min).
- Liver function compromised (Child Pugh B, MELD score > 9)
- Indirect sign of portal hypertension (Oesophagal Varices, splenomegaly, platelet count less than 100.000)
- A need for major hepatic resection (more than 2 segments)
- Taking digoxin (digitalis) within 6 months of starting treatment.
- History of severe hypersensitivity reaction (such as anaphylactic shock or angioedema) to sitagliptin.
- Patients with diabetes.
- Pregnant or absence of an effective contraception for women.
- A person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.
- Living conditions suggesting an inability to track all scheduled visits by the protocol.
- Life expectancy less than 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DPPIV Inhibition
The study will include 3 weeks administration (± 7 days) of sitagliptin as monotherapy (taken orally).
The study will use 3 doses: the first five patients will receive 100 mg/day, the next five 200 mg/day and the last five patients 600 mg/day.
During this time, arrangements will be made for surgical resection, as per the standard of care treatment of patients.
Blood samples will be obtained for immunology studies.
The study will end one week after surgery.
Patients will continue their treatment for HCC as prescribed by the clinician.
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100mg or 200mg or 600mg, daily for 3 weeks ± 7 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety (Number of adverse events. Toxicity grade > 3)
Time Frame: After Day 0 until the end of the trial, i.e. a duration of 3 weeks +/- 7 days for each patient
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After Day 0 until the end of the trial, i.e. a duration of 3 weeks +/- 7 days for each patient
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DPPIV Activity
Time Frame: Baseline; week 1, 3 of sitagliptin therapy , 3 days after end of sitagliptin therapy
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Plasma concentration and activity of DPPIV (measured using an ELISA and a luciferase bioassay, respectively).
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Baseline; week 1, 3 of sitagliptin therapy , 3 days after end of sitagliptin therapy
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CXCL10 truncation
Time Frame: Baseline; week 1, 3 of sitgaliptin therapy, 3 days after end of sitagliptin therapy
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Monitoring the short and the long form of IP-10 as compared to the total plasma concentration (three distinct ELISA assays).
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Baseline; week 1, 3 of sitgaliptin therapy, 3 days after end of sitagliptin therapy
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Immune cells trafficking
Time Frame: Baseline; week 1, 3 of sitagliptin therapy, 3 days after end of sitagliptin therapy
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Frequency of CXCR3+ cells in circulation (monitored by FACS).
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Baseline; week 1, 3 of sitagliptin therapy, 3 days after end of sitagliptin therapy
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Infiltration of leucocytes in tumor tissue
Time Frame: Baseline, week 3 of sitagliptin therapy
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Histochemical method with a panel of Ab.
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Baseline, week 3 of sitagliptin therapy
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Collaborators and Investigators
Investigators
- Principal Investigator: Olivier SCATTON, Pitié-Salpêtrière Hospital, Paris, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma, Hepatocellular
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
Other Study ID Numbers
- C15-41
- 2015-002968-17 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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