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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02409524 |
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Date of registration:
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01/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects
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Scientific title:
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Phase IIA Clinical Study Of An Individualized Anti-Cancer Vaccine (CRCL-ALLOVAX) in Subjects With Advanced Hepatocellular Carcinoma |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02409524 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Wirote Lausoontornsiri, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Cancer Institute (NCI) |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Males and females who are at least 18 years of age at time of enrollment
2. Histologically confirmed hepatocellular carcinoma with or without positive HBV and/or
HCV, not candidate for local regional intervention
3. Minimum of 90 days of sorafenib treatment or ineligible for sorafenib
4. Child-Pugh Stage A-B (score = 5 and = 9)
5. Performance status: ECOG < 2 with no deterioration over the previous 2 weeks
6. Measurable disease (for mRECIST)
7. Lesion amenable for percutaneous tumor harvest and follow up biopsy
8. Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin > 10.0 g/dl
- Absolute neutrophil count (ANC) > 1,500/mm3
- Platelet count > 75,000/µl
- ALT and AST < 2.5 x ULN
- Alkaline phosphatase < 4 x ULN
- Serum creatinine < 1.5
9. Women of child-bearing potential: negative pregnancy test
10. Patients of child producing potential: usage of contraception or avoidance of
pregnancy measures while enrolled on study and receiving the experimental product
11. Ability to understand the study, its inherent risks, side effects and potential
benefits and ability to give written informed consent to participate
Exclusion criteria:
1. Severe ascites, massive or uncontrolled (+3 on Child-Pugh calculator)
2. Severe encephalopathy, uncontrolled (+3 on Child-Pugh calculator)
3. INR > 1.5
4. Participation in another clinical trial evaluating experimental treatments or
procedures or receiving medication/treatment for HCC other than sorafenib
5. Any autoimmune disorder
6. Any clinical condition requiring systemic steroids or current immunosuppressive
therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month
of study entry
7. HIV positive or syphilis
8. History of cardiac disease: congestive heart failure > NYHA class 2; cardiac
arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted)
or uncontrolled hypertension
9. Active clinically serious infections (> grade 2 NCI-CTCAE version 4.0)
10. History of organ or tissue allograft
11. Advanced liver cirrhosis
12. Interferon or thalidomide within 1 month prior to signing informed consent
13. Uncontrolled concurrent serious medical or psychiatric illness
14. Clinically apparent central nervous system metastases or carcinomatous meningitis
15. History of blood transfusion reactions
16. Known allergy to murine monoclonal antibodies or bovine products or cow milk
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Advanced Adult Hepatocellular Carcinoma
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Intervention(s)
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Biological: AlloStim
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Biological: AlloVax
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Biological: CRCL
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Primary Outcome(s)
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To evaluate survival compared to historical controls
[Time Frame: Approximately 12 months]
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Secondary Outcome(s)
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To assess AFP as surrogate end-point for response and/or survival
[Time Frame: Approximately 6 months]
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To assess mRECIST as surrogate end-point for response and/or survival
[Time Frame: Approximately 6 months]
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To evaluate safety in advanced HCC (adverse events)
[Time Frame: Approximately 6 months]
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Secondary ID(s)
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ITL-022-HCC-BKK-VAX+S
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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