NCT03185429

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: BGI, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Tumor Gastric
• Tumor, Colorectal

Interventions

Type	Name	Description
BIOLOGICAL	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.
DRUG	Cyclophosphamide	300 mg/m2 by vein before the first cell infusion.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-12-01
• Completion: 2019-06-01
• First posted: 2017-06-14
• Last updated: 2017-08-14