Tumor GastricNCT03185429
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor
A study testing Tumor Specific Antigen-loaded Dendritic Cells and Cyclophosphamide in people with Tumor Gastric and Tumor, Colorectal, run by BGI, China.
Trial summary
The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tumor Gastric, Tumor, Colorectal
- What is being tested?
- Tumor Specific Antigen-loaded Dendritic Cells and Cyclophosphamide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Jun 2019
- Phase
- Interventional
- 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
- Be ≥18 and ≤75,no gender based;
- Expression of HLA-A0201/1101/2402;
- Histopathologic documentation of gastrointestinal solid tumors(stomach cancer or colorectal cancer ) concurrent with the diagnosis of metastatic disease, and the tumor is Measurable;
- Patients must have adequate tissue (fresh or paraffin block) for DNA extraction, which is used for gene sequencing, and prognoses the tumor specific antigen in turn,can predict to have new tumor antigens with high affinity for MHC molecules;
- Failure in conventional treatment， or though benefit from chemotherapy the patient can't tolerant subjectively;
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 and an anticipate life expectancy of at least three months,be cooperate to adverse reactions monitoring and therapeutic evaluation of the treatment;
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- Participants of child-bearing potential must agree to use adequate contraceptive methods up to 12 months after the pretreatment;
- Serology：Seronegative for HIV antibody,seronegative for hepatitis C antibody. Hematology：Absolute neutrophil count ≥ 1000/mm(3) without the support of filgrastim ,WBC ≥ 3000/mm(3)，lymphocyte count ≥ 800/mm(3)，Platelet count ≥ 100,000/mm(3)，Hemoglobin ≥ 9.0 g/dl Chemistry：Serum ALT/AST ≤ 2.5 times the upper limit of normal，Serum Creatinine ≤1.6 mg/dl，Total bilirubin < 1.5 mg/dl, except in patients with Gilbert s Syndrome who must have a total bilirubin < 3.0 mg/dl;
- Patients or their legal representatives are willing and able to understand and written informed consent form for the trial;
Who cannot join
- Is pregnant or breastfeeding,or expecting to conceive;
- Have a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Suffered grade 3-4 major organ immune-related adverse events after anti-PD1/PDL1 antibody treatment.
- Once received allogeneic organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation, except for corneal transplantation);
- Have clinical symptoms of central nervous system metastases;
- Have used a large number of glucocorticoids or other immunosuppressive agents within 4 weeks;
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- Have any active autoimmune disease ;
- Be in active infection or undergo an unknown cause fever> 38.5 ℃ during screening or before the first administration(except tumor fever which evaluated by the researchers have no effect to enrollment );
- Received chemotherapy or small molecule targeted drug therapy in 4 weeks prior to chemotherapy pretreatment;
- Received any antibody drug therapy (including PD-1 and CTLA-4) within 6 weeks before the treatment period;
- Severe liver and kidney dysfunction or uncontrollable diabetes, hypertension and other chronic systemic diseases; severe coagulation disorders, mental illness, cardiopulmonary disease，hydrothorax or ascites;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of DC Vaccine Loaded Tumor Specific Antigen in Treating Patients With Gastrointestinal Solid Tumor
The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.
Read the detailed description
20 gastrointestinal solid tumor subjects failed from at least one systemic therapy will be enrolled into the trial .Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1, 3, 5, 11,17,23,35,47. Before the first cell infusion, the subjects should undergo a non-myeloablative chemotherapy regimen of Cyclophosphamide 300mg/m2 iv. Radiologic tumor assessment will be repeated every 8 weeks during treatment, until time of progression. Treatment will continue until disease progression, intolerance of toxic , withdrawal from the study, study completion, or study termination.
- Conditions
- Tumor Gastric, Tumor, Colorectal
- Being tested
- Tumor Specific Antigen-loaded Dendritic Cells, Cyclophosphamide
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Specific Antigen-loaded Dendritic CellsBiological
Also called TSA-DC vaccine
Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1,3,5,11,17,23,35,47.
CyclophosphamideDrug
Also called Cytoxan
300 mg/m2 by vein before the first cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Drug:Cyclophosphamide
Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells Receives: Biological: Tumor Specific Antigen-loaded Dendritic Cells; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety endpoint
All the local or systemic reactions, adverse events and serious adverse events that occurred between the first and the second TSA-DC administration.
Measured: one year
Overall Response Rate
Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time.
Measured: one year
Proportion of the number of cases that has produced tumor-specific antigen-specific T cells in peripheral blood.
Measured: one year
Secondary outcomes (6)
Secondary safety endpoint
All local or systemic reactions, adverse events and serious adverse events that occurred from entering the trial until 30 days after the last treatment;
Measured: one year
Six month DCR(CRR+PRR+SDR)
Percentage of cases with no progression (CR + PR + SD) in 6 months after initiation of treatment;
Measured: 6 month
Duration of Response(DOR)
The time from the first tumor evaluation of remission(CR + PR ) till the first assessment of PD or the end the study.
Measured: one year
Progression-free survival(PFS)
The time from entering the trial till the subject has been diagnosed with progression of disease or died.
Measured: one year
rate of 12-month survival
Percentage of cases with 12 months survival after initiation of treatment in all the subjects;
Measured: one year
Quality score of life improvement
Evaluated by the questionnaire of life improvement quality collected from the screening to treatment periods.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tumor GastricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BGI, China
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- ZengQing Guo, Professor, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185429
- Sponsor's protocol ID
- BGI-002
- Status last verified
- Aug 2017
- First submitted
- 11 Jun 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chiang CL, Kandalaft LE, Tanyi J, Hagemann AR, Motz GT, Svoronos N, Montone K, Mantia-Smaldone GM, Smith L, Nisenbaum HL, Levine BL, Kalos M, Czerniecki BJ, Torigian DA, Powell DJ Jr, Mick R, Coukos G. A dendritic cell vaccine pulsed with autologous hypochlorous acid-oxidized ovarian cancer lysate primes effective broad antitumor immunity: from bench to bedside. Clin Cancer Res. 2013 Sep 1;19(17):4801-15. doi: 10.1158/1078-0432.CCR-13-1185. Epub 2013 Jul 9.
PubMed 23838316Schuler PJ, Harasymczuk M, Visus C, Deleo A, Trivedi S, Lei Y, Argiris A, Gooding W, Butterfield LH, Whiteside TL, Ferris RL. Phase I dendritic cell p53 peptide vaccine for head and neck cancer. Clin Cancer Res. 2014 May 1;20(9):2433-44. doi: 10.1158/1078-0432.CCR-13-2617. Epub 2014 Feb 28.
PubMed 24583792Carreno BM, Magrini V, Becker-Hapak M, Kaabinejadian S, Hundal J, Petti AA, Ly A, Lie WR, Hildebrand WH, Mardis ER, Linette GP. Cancer immunotherapy. A dendritic cell vaccine increases the breadth and diversity of melanoma neoantigen-specific T cells. Science. 2015 May 15;348(6236):803-8. doi: 10.1126/science.aaa3828. Epub 2015 Apr 2.
PubMed 25837513
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of DC Vaccine Loaded Tumor Specific Antigen in Treating Patients With Gastrointestinal Solid Tumor
- ClinicalTrials.gov ID
- NCT03185429
- Acronym / sponsor ID
- BGI-002
- Conditions
- Tumor Gastric, Tumor, Colorectal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BGI, ChinaUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.
Detailed description
20 gastrointestinal solid tumor subjects failed from at least one systemic therapy will be enrolled into the trial .Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1, 3, 5, 11,17,23,35,47. Before the first cell infusion, the subjects should undergo a non-myeloablative chemotherapy regimen of Cyclophosphamide 300mg/m2 iv. Radiologic tumor assessment will be repeated every 8 weeks during treatment, until time of progression. Treatment will continue until disease progression, intolerance of toxic , withdrawal from the study, study completion, or study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: Tumor Specific Antigen-loaded Dendritic Cells, Drug: CyclophosphamideDrug:Cyclophosphamide Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be ≥18 and ≤75,no gender based;
- Expression of HLA-A0201/1101/2402;
- Histopathologic documentation of gastrointestinal solid tumors(stomach cancer or colorectal cancer ) concurrent with the diagnosis of metastatic disease, and the tumor is Measurable;
- Patients must have adequate tissue (fresh or paraffin block) for DNA extraction, which is used for gene sequencing, and prognoses the tumor specific antigen in turn,can predict to have new tumor antigens with high affinity for MHC molecules;
- Failure in conventional treatment， or though benefit from chemotherapy the patient can't tolerant subjectively;
Key exclusion criteria (11 listed)
- Is pregnant or breastfeeding,or expecting to conceive;
- Have a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Suffered grade 3-4 major organ immune-related adverse events after anti-PD1/PDL1 antibody treatment.
- Once received allogeneic organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation, except for corneal transplantation);
- Have clinical symptoms of central nervous system metastases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor Specific Antigen-loaded Dendritic CellsAlso: TSA-DC vaccineSubjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1,3,5,11,17,23,35,47. | Biological | Experimental |
| CyclophosphamideAlso: Cytoxan300 mg/m2 by vein before the first cell infusion. | Drug | Experimental |
Primary outcome
safety endpoint
Time frame: one year
All the local or systemic reactions, adverse events and serious adverse events that occurred between the first and the second TSA-DC administration.
Overall Response Rate
Time frame: one year
Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time.
Proportion of the number of cases that has produced tumor-specific antigen-specific T cells in peripheral blood.
Time frame: one year
6 secondary outcomes
Secondary safety endpoint
Time frame: one year
Six month DCR(CRR+PRR+SDR)
Time frame: 6 month
Duration of Response(DOR)
Time frame: one year
Progression-free survival(PFS)
Time frame: one year
rate of 12-month survival
Time frame: one year
Quality score of life improvement
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Background: PubMed 23838316Chiang CL, Kandalaft LE, Tanyi J, Hagemann AR, Motz GT, Svoronos N, Montone K, Mantia-Smaldone GM, Smith L, Nisenbaum HL, Levine BL, Kalos M, Czerniecki BJ, Torigian DA, Powell DJ Jr, Mick R, Coukos G. A dendritic cell vaccine pulsed with autologous hypochlorous acid-oxidized ovarian cancer lysate primes effective broad antitumor immunity: from bench to bedside. Clin Cancer Res. 2013 Sep 1;19(17):4801-15. doi: 10.1158/1078-0432.CCR-13-1185. Epub 2013 Jul 9.
- Background: PubMed 24583792Schuler PJ, Harasymczuk M, Visus C, Deleo A, Trivedi S, Lei Y, Argiris A, Gooding W, Butterfield LH, Whiteside TL, Ferris RL. Phase I dendritic cell p53 peptide vaccine for head and neck cancer. Clin Cancer Res. 2014 May 1;20(9):2433-44. doi: 10.1158/1078-0432.CCR-13-2617. Epub 2014 Feb 28.
- Background: PubMed 25837513Carreno BM, Magrini V, Becker-Hapak M, Kaabinejadian S, Hundal J, Petti AA, Ly A, Lie WR, Hildebrand WH, Mardis ER, Linette GP. Cancer immunotherapy. A dendritic cell vaccine increases the breadth and diversity of melanoma neoantigen-specific T cells. Science. 2015 May 15;348(6236):803-8. doi: 10.1126/science.aaa3828. Epub 2015 Apr 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZengQing Guo, Professor principal investigator
Fujian Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Tumor Specific Antigen-loaded Dendritic Cells and Cyclophosphamide in people with Tumor Gastric and Tumor, Colorectal, run by BGI, 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 11 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Yu Chen, Doctor (13859089836, fannychenling05@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety endpoint (time frame: one year). The study lists 3 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 NCT03185429, which also lists 3 linked publications.
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 14 Aug 2017.