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

NCT ID: NCT04206254

Last Updated: 2019-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2023-08-05

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.

Conditions

Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gp96 group

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.

Group Type: EXPERIMENTAL

gp96

Intervention Type: BIOLOGICAL

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.

Control group

Patients do not accept any anti-tumor treatmentsafter surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

gp96

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Cure&Sure Biotech Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CS-CH-19

Identifier Type: -

Identifier Source: org_study_id