Peptides pulsed dendritic cell vaccine for hepatocellular carcinoma

Phase 1

Recruiting

• Conditions: Hepatocellular carcinoma; Liver cancer

• Registration Number: JPRN-jRCTc040190093
• Lead Sponsor: Mizukoshi Eishiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1) The patient was clinically diagnosed with hepatocellular carcinoma (on histology or imaging).
2) It was judged to be the adaptation of percutaneous local treatment, and RFA was carried out.
3) It has been confirmed that the good cauterization necrosis was obtained in the node which was made to be the treatment object of RFA.
4) Adverse events (Pyrexia, pain, etc.) due to RFA have not disappeared or worsened.
5) Patients with HLA (Human Leukocyte Antigen) -A24 positive human tumor histocompatibility antigen.
6) Child-Pugh classification is A or B.
7) Age at entry (full age) is 20 years or older.
8) The ECOG Performance status is not more than 1 (0-1).
9) The most recent test result within 14 days before registration satisfies all of the following.
WBC > 2,000/mm3
Hemoglobin > 8.5 g/dl
Platelet count > 50,000/mm3
Serum creatinine < 1.5 mg/dl
10) The patient has given written consent to the study.

Exclusion Criteria

1) Untreatable ascites and moderate or severe pleural effusion were confirmed.
2) The patient had a history of hepatic encephalopathy within 3 months before registration.
3) Esophagogastric varices at risk of bleeding have been identified, and no preventive measures have been taken.
4) The patient has an active malignant tumor.
5) Blood transfusions, blood products (Contain a preparation of albumin), and blood enhancing factor products such as G-CSF were administered within 2 weeks before enrollment.
6) The patient received continuous systemic administration of steroids or other immunosuppressants (Oral or intravenous administration).
7) The patient had serious complications (Cardiac failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, poorly controlled diabetes mellitus, etc.).
8) If you are a patient with infection (except for viral hepatitis) requiring systemic treatment.
9) Women who are pregnant, possibly pregnant, within 28 days after childbirth, or breastfeeding. A man who wishes to conceive his partner.
10) It is judged that participation in the test is difficult because mental disease or mental manifestation is combined.
11) The patient has serious hypersensitivity to components of peptide-stimulated dendritic cells.
12) Neither CT nor MRI with contrast agent can be performed due to drug allergy.
13) In addition, the attending physician determines that participation in this study is inappropriate.

Study & Design

• Study Type: Other
• Study Design: Not specified