GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer

Cure&Sure Biotech

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Liver Cancer

Treatments: Biological: gp96

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04206254

CS-CH-19

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

gp96 group

Experimental group

Description:

Patients only receive autologous gp96 vaccination after surgery (do not accept other anti-tumor treatments) 6 times of gp96 vaccination are administered via subcutaneous injection in 25μg doses within 8 weeks after surgery. gp96 is administered once a week.

Treatment:

Biological: gp96

Control group

No Intervention group

Description:

Patients do not accept any anti-tumor treatmentsafter surgery