Neoplasms

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Stomach Neoplasms

Colorectal Neoplasms

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Cancer

Antineoplastic Agents

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Cyclophosphamide

Vaccines

Immunologic Factors

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Alkylating Agents

Drug:Cyclophosphamide

Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells

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.

Tumor Specific Antigen-loaded Dendritic Cells

300 mg/m2 by vein before the first cell infusion.

Yu Chen, Doctor

ZengQing Guo, Professor

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.

TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor

Study of DC Vaccine Loaded Tumor Specific Antigen in Treating Patients With Gastrointestinal Solid Tumor

All the local or systemic reactions, adverse events and serious adverse events that occurred between the first and the second TSA-DC administration.

Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time.

All local or systemic reactions, adverse events and serious adverse events that occurred from entering the trial until 30 days after the last treatment;

Percentage of cases with no progression (CR + PR + SD) in 6 months after initiation of treatment;

The time from the first tumor evaluation of remission(CR + PR ) till the first assessment of PD or the end the study.

The time from entering the trial till the subject has been diagnosed with progression of disease or died.

Percentage of cases with 12 months survival after initiation of treatment in all the subjects;

Evaluated by the questionnaire of life improvement quality collected from the screening to treatment periods.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor	NCT03185429	Tumor Gastric Tumor, Colorect...	Tumor Specific ... Cyclophosphamid...	18 Years - 75 Years	BGI, China
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor	NCT03185429	Tumor Gastric Tumor, Colorect...	Tumor Specific ... Cyclophosphamid...	18 Years - 75 Years	BGI, China
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor	NCT03185429	Tumor Gastric Tumor, Colorect...	Tumor Specific ... Cyclophosphamid...	18 Years - 75 Years	BGI, China

Spots Global Cancer Trial Database for tumor, colorectal