AzTrials
AzTrials

Liver CancerPhase 1/2NCT02133079

Immunotherapy of Tumor With Autologous Tumor Derived Heat Shock Protein gp96

A Phase 1/2 study testing autologous gp96 vaccination in people with Liver Cancer and Pancreatic Adenocarcinoma, run by Cure&Sure Biotech Co., LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and Pancreatic Adenocarcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Liver Cancer, Pancreatic Adenocarcinoma
What is being tested?
autologous gp96 vaccination
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Mar 2012to Nov 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
Show all 9Show fewer
  • 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;
  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Insititute and Hospital,Chinese Academy of Medical Sciences

    Beijing, 100021

Other trials in China

About this study

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

Being tested
autologous gp96 vaccination
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous gp96 vaccinationBiological

    vaccination of autologous gp96 derived from tumor tissue + basal treatment

Study groups in NCT02133079
Study groupRoleWhat they receive
gp96 groupExperimentalautologous gp96 vaccination + basal treatment
Receives: Biological: autologous gp96 vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. blood count

    blood count within 3 days before first vaccination

    Measured: baseline

  2. blood count

    blood count within 3 days after the second injection

    Measured: within 3 days after the second injection

  3. blood count

    blood count within 3 days after the 6th injection

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: within 3 days after the 6th injection

  7. electrocardiogram

    electrocardiogram test within 3 days before first vaccination

    Measured: baseline

  8. electrocardiogram

    electrocardiogram test within 3 days after the second injection

    Measured: within 3 days after the second injection

  9. electrocardiogram

    electrocardiogram test within 3 days after the 6th injection

    Measured: within 3 days after the 6th injection

Secondary outcomes (3)

  1. Disease-free survival

    Measured: up to 3 years

  2. overall survive

    Measured: 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.

    Measured: baseline and within 3 days before the 6th injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2014 (estimated)
  2. Study startMar 2012
  3. Primary completionNov 2016 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133079
Sponsor's protocol ID
CS-CIH-Li-01
Status last verified
Dec 2015
First submitted
3 May 2014
Last updated
11 Dec 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing autologous gp96 vaccination in people with Liver Cancer and Pancreatic Adenocarcinoma, run by Cure&Sure Biotech Co., LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood count (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02133079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in