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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04206254
• Other study ID #: CS-CH-19
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 19, 2019
• Est. completion date: August 5, 2023

Study information

• Verified date: August 2019
• Source: Cure&Sure Biotech Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 5, 2023
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cure&Sure Biotech Co., LTD	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year recurrence-free survival rate		2 year
Secondary	Disease free survival		5 year
Secondary	changes in antigen specific T cells	tumor antigen specific T cells are determined by IFN-? Enzyme-linked Tumor antigen specific T cells will be determined by IFN-? Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen	within 3 days before the first vaccination and within 10 days after the last vaccination
Secondary	Number of participants with adverse events related to gp96 immunotherapy	A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria.	up to 3 months after vaccine completion
Secondary	Overall survival		5 year