Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

NCT02133079 | Unknown Phase 1 DMC

• 1 other identifier: CS-CIH-Li-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma

Conditions

Liver Cancer; Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (9)

• blood count

  blood count within 3 days before first vaccination

  baseline

• blood count

  blood count within 3 days after the second injection

  within 3 days after the second injection

• blood count

  blood count within 3 days after the 6th injection

  within 3 days after the 6th injection

• blood chemistries

  blood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], serum alanine amino transferase \[ALT\], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen\[BUN\], serum creatinine, serum total protein and serum albumin) within 3 days before first vaccination

  baseline

• blood chemistries

  blood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], serum alanine amino transferase \[ALT\], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen\[BUN\], serum creatinine, serum total protein and serum albumin) within 3 days after the second injection

  within 3 days after the second injection

• blood chemistries

  blood chemistries (including serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], serum alanine amino transferase \[ALT\], serum alkaline phosphatase, serum total bilirubin, serum blood urea nitrogen\[BUN\], serum creatinine, serum total protein and serum albumin) within 3 days after the 6th injection

  within 3 days after the 6th injection

• electrocardiogram

  electrocardiogram test within 3 days before first vaccination

  baseline

• electrocardiogram

  electrocardiogram test within 3 days after the second injection

  within 3 days after the second injection

• electrocardiogram

  electrocardiogram test within 3 days after the 6th injection

  within 3 days after the 6th injection

Secondary Outcomes (3)

• Disease-free survival

  up to 3 years

• overall survive

  up to 3 years

• changes in antigen specific T cells

  baseline and within 3 days before the 6th injection

Other Outcomes (1)

• Change from baseline in subpopulation of CD8+ T cells at the end of vaccination

  within 3 days before the first vaccination, within 3 days after the 6th vaccination

Study Arms (1)

gp96 group

EXPERIMENTAL

autologous gp96 vaccination + basal treatment

Biological: autologous gp96 vaccination

Interventions

autologous gp96 vaccination BIOLOGICAL

vaccination of autologous gp96 derived from tumor tissue + basal treatment

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;
• Pancreatic cancer or primary liver cancer,must have undergone radical resection;
• Availability of at least 0.5 g tumor sample;
• Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation;
• Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment；
• ECOG ≤1；life expectancy of at least 12 weeks
• 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 bilirubin (total) \<1.5 times IULN), and adequate renal function (BUN and creatinine \<1.5 times IULNs); 9. Agree to Surgical indications of Heart \& lung and without the coagulation system disease;
• Negative pregnancy test for female patients of childbearing potential; 11.Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration.

You may not qualify if:

• Unable to get the informed consent ;
• Patient not suitable for radical resection;
• Patients with active liver disease；
• Did not get enough tumor tissue ;
• Progression prior to vaccination as determined by the Principal Investigator;
• Rreceiving other anti-cancer therapy at the same time;
• Patient with allergic constitution;
• 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;
• Any other cilical trials within 30 days pre-vaccination;
• Female patients who are pregnant or breastfeeding.

Sponsors & Collaborators

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

Study Sites (1)

Cancer Insititute and Hospital,Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jianqiang Cai, meidical

  Cancer Insititute and Hospital,Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Lei Yu, medical

  Cancer Insititute and Hospital,Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2014
• First Posted: May 7, 2014
• Study Start: March 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2019
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

CN (1)