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Status unknownNCT02133079Updated Dec 11, 2015

Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

A Phase 1/2 interventional study of autologous gp96 vaccination in Liver Cancer and Pancreatic Adenocarcinoma, sponsored by Cure&Sure Biotech Co., LTD. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-12-11.

Sponsored by Cure&Sure Biotech Co., LTD · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Liver Cancer
  • Pancreatic Adenocarcinoma
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Cure&Sure Biotech Co., LTD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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. Pancreatic cancer or primary liver cancer,must have undergone radical resection;
  4. Availability of at least 0.5 g tumor sample;
  5. Receiving the first gp96 autologous immunotherapy within 8 weeks of postoperation;
  6. Patients could not have received previous chemotherapy, radiation, or immunotherapy before 4 weeks of gp96 treatment；
  7. ECOG ≤1；life expectancy of at least 12 weeks
  8. 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;

10.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.

Exclusion criteria

Exclusion Criteria:

  1. Unable to get the informed consent ;
  2. Patient not suitable for radical resection;
  3. Patients with active liver disease；
  4. Did not get enough tumor tissue ;
  5. Progression prior to vaccination as determined by the Principal Investigator;
  6. Rreceiving other anti-cancer therapy at the same time;
  7. Patient with allergic constitution;
  8. Unstable or severe intercurrent medical conditions;
  9. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection;
  10. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids;
  11. Any other cilical trials within 30 days pre-vaccination;
  12. Female patients who are pregnant or breastfeeding.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    gp96 group

    autologous gp96 vaccination + basal treatment

    Biological: autologous gp96 vaccination

Interventions

  • Biologicalautologous gp96 vaccination

    vaccination of autologous gp96 derived from tumor tissue + basal treatment

06

What researchers measure

Primary outcomes

  1. blood count

    blood count within 3 days before first vaccination

    Time frame: baseline

  2. blood count

    blood count within 3 days after the second injection

    Time frame: within 3 days after the second injection

  3. blood count

    blood count within 3 days after the 6th injection

    Time frame: within 3 days after the 6th injection

  4. 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

    Time frame: baseline

  5. 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

    Time frame: within 3 days after the second injection

  6. 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

    Time frame: within 3 days after the 6th injection

  7. electrocardiogram

    electrocardiogram test within 3 days before first vaccination

    Time frame: baseline

  8. electrocardiogram

    electrocardiogram test within 3 days after the second injection

    Time frame: within 3 days after the second injection

  9. electrocardiogram

    electrocardiogram test within 3 days after the 6th injection

    Time frame: within 3 days after the 6th injection

Secondary outcomes

  1. Disease-free survival

    Time frame: up to 3 years

  2. overall survive

    Time frame: up to 3 years

  3. changes in antigen specific T cells

    tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.

    Time frame: 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

    analysis of the expression of CCR7 \& CD45RA of CD8+ T cells by FCM within 3 days before first vaccination and within 3 days after the 6th vaccination.

    Time frame: within 3 days before the first vaccination, within 3 days after the 6th vaccination

07

Study locations

1 site
  • Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
    Beijing, 100021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02133079
Lead sponsor
Cure&Sure Biotech Co., LTD
Collaborators
Chinese Academy of Medical Sciences
Responsible party
Sponsor
First posted
May 7, 2014
Start date
Mar 2012
Primary completion
Nov 2016 (estimated)
Completion
Nov 2019 (estimated)
Last update
Dec 11, 2015

Study contacts

Jianqiang Cai, meidical
principal investigator · Cancer Insititute and Hospital,Chinese Academy of Medical Sciences
Lei Yu, medical
principal investigator · Cancer Insititute and Hospital,Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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