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| Name | Class |
|---|---|
| Fujian Cancer Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Drug:Cyclophosphamide Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Specific Antigen-loaded Dendritic Cells | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year |
| Overall Response Rate | Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time. | one year |
| Proportion of the number of cases that has produced tumor-specific antigen-specific T cells in peripheral blood. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | one year |
| Six month DCR(CRR+PRR+SDR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Chen, Doctor | Contact | 13859089836 | fannychenling05@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| ZengQing Guo, Professor | Fujian Cancer Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23838316 | Background | 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. | |
| 24583792 |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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|
| Cyclophosphamide | Drug | 300 mg/m2 by vein before the first cell infusion. |
|
|
Percentage of cases with no progression (CR + PR + SD) in 6 months after initiation of treatment;
| 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. | one year |
| Progression-free survival(PFS) | The time from entering the trial till the subject has been diagnosed with progression of disease or died. | one year |
| rate of 12-month survival | Percentage of cases with 12 months survival after initiation of treatment in all the subjects; | one year |
| Quality score of life improvement | Evaluated by the questionnaire of life improvement quality collected from the screening to treatment periods. | one year |
| Background |
| Schuler 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. |
| 25837513 | Background | Carreno 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |