This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gastrointestinal tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.
Shanghai Tenth People's Hospital
Shanghai, China
RECRUITINGObjective Response Rate (ORR)
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before TIL infusion,PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 1 year, and then every six months after that for up to 3 years)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
Time frame: Up to 36 months
Change in Quality of Life
Comparison of patients' quality of life before and after TIL treatment as assessed by the EORTC QLQ-30 (V3.0).
Time frame: Up to 36 months
Duration of Response (DOR)
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Time frame: Up to 36 months
Overall Survival (OS)
The length of time from the date of the start of TIL treatment that the patients are still alive
Time frame: Up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.