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

NCT04206254 | Unknown Phase 2

• 1 other identifier: CS-CH-19
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence-free survival rate

  2 year

Secondary Outcomes (4)

• Disease free survival

  5 year

• changes in antigen specific T cells

  within 3 days before the first vaccination and within 10 days after the last vaccination

• Number of participants with adverse events related to gp96 immunotherapy

  up to 3 months after vaccine completion

• Overall survival

  5 year

Study Arms (2)

gp96 group

EXPERIMENTAL

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.

Biological: gp96

Control group

NO INTERVENTION

Patients do not accept any anti-tumor treatmentsafter surgery

Interventions

gp96 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.

gp96 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and understand the informed consent document; must sign the informed consent;
• Aged 18 to 75 years old , sex is not limited;
• must have undergone radical resection;AJCC TNM II、III、IV.
• Availability of at least 1g tumor sample;
• 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)
• Agree to Surgical indications of Heart \& lung and without the coagulation system disease
• Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment；

You may not qualify if:

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

Sponsors & Collaborators

• Cure&Sure Biotech Co., LTD: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

MeSH Terms

Conditions

Liver Neoplasms

Interventions

glucose-regulated proteins

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: December 19, 2019
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2023
• Last Updated: December 20, 2019

Record last verified: 2019-08