Clinical trial NCT04206254: GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer
Official title: GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Liver Cancer
Lead sponsor: Cure&Sure Biotech Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2019-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work

Detailed description: RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.

Overall Goals:

- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.

Primary Aim:

- to further evaluate effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work.

Secondary Aims:

to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.

Eligibility criteria: Inclusion Criteria:

1. Able to read and understand the informed consent document; must sign the informed consent;
2. Aged 18 to 75 years old , sex is not limited;
3. must have undergone radical resection;AJCC TNM II、III、IV.
4. Availability of at least 1g tumor sample;
5. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] ), and adequate renal function (BUN and creatinine \<1.5 times IULNs)
6. Agree to Surgical indications of Heart \& lung and without the coagulation system disease
7. Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment；

Exclusion Criteria:

1. Inability to comply with study-related procedures
2. Unavailability of at least 6 doses of vaccine
3. Severe allergies
4. Unstable or severe intercurrent medical conditions
5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
7. Female patients who are pregnant or breastfeeding
8. Steroidal drugs are currently being used systemically.

Primary outcomes:
measure: 2-year recurrence-free survival rate
timeFrame: 2 year
Secondary outcomes:
measure: Disease free survival
timeFrame: 5 year
measure: changes in antigen specific T cells
timeFrame: within 3 days before the first vaccination and within 10 days after the last vaccination
measure: Number of participants with adverse events related to gp96 immunotherapy
timeFrame: up to 3 months after vaccine completion
measure: Overall survival
timeFrame: 5 year
Other outcomes:
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Study officials:
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