A phase I study of NY-ESO-1b peptide mixed with Montanide ISA-51VG combined with GM-CSF in patients of hepatocellular carcinoma after tumor resection

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-08000266

Enrollment

Unknown

Registered

2008-11-26

Start date

2008-07-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary hepatocellular carcinoma

Interventions

Arm B:Montanide ISA-51 (0.5 mL) and GM-CSF (75 ug).

Arm A:NY-ESO-1b peptide (100ug) mixed with Montanide ISA-51 (0.5 mL) (Total Volume: 1.0 mL) and GM-CSF (75 ug).

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients will be eligible for enrollment if they fulfill the following criteria: 1. Histological diagnosis of hepatocellular carcinoma; 2. Tumor expression of NY-ESO-1 by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis (see Appendix 1) or immunohistochemistry (Jungbluth 2001); 3. Minimal residual disease after surgical resection of tumor; 4. HLA A02 positive; 5. Child's A cirrhosis (if cirrhotic); 6. At least 4 weeks since surgery prior to first dosing of study agent; 7. Laboratory values within the following limits: Hemoglobin >11.0 g/dL;Neutrophil count >1.5*l0^9/L; Lymphocyte count >Lower limit of institutional normal; Platelet count >80*l0^9/L; Serum creatmine 60%; 9. Life expectancy > 9 months; 10. Age: 18 years to 65 years; 11. To be able to and willing to give witnessed, written informed consent for participation in the trial (see Section 12.2).

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they fulfill any of the following criteria: 1. Clinically significant heart disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias); 2. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders; 3. Previous bone marrow or stem cell transplant; 4. History of immunodeficiency disease or autoimmune disease except vitiligo; 5. Metastatic disease to the central nervous system, unless treated and stable; 6. Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ; 7. Known HIV positivity; 8. Chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to first dose of study agent (6 weeks for nitrosoureas); 9. Concomitant treatment with steroids. Topical or inhalational steroids are permitted. (See also Section 6.7 for restrictions/recommendations on 'Ancillary Therapy'); 10. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent; 11. Pregnancy or lactation; 12. Women of childbearing potential not using a medically acceptable means of contraception; 13. Psychiatric or addictive disorders that may compromise the ability to give informed consent; 14. Lack of availability of the patient for immunological and clinical follow-up assessment.

Design outcomes

Primary

Measure	Time frame
Security;	—

Secondary

Measure	Time frame
immunological response;	—

Countries

China

Contacts

Public ContactWeifeng Chen

junzhang@bjmu.edu.cn+86 010 82802593

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026