Prospective, multicenter, single-arm, open label, interventional basket trial to evaluate autologous tumor-infiltrating lymphocytes (TILs) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparation for the treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.
Autologous tumor-infiltrating lymphocytes (TILs) infusion is highly personalized cancer immunotherapy with strong anti-tumor efficacy and tumor specificity. TILs were extracted from autologous fresh tumor tissues, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients. TIL-based therapies have only been offered in small phase I/II studies in a few centers and revealed a high objective response rate (ORR) in the treatment of metastatic, recurrent or advanced melanoma, non-small cell long carcinoma and cervical carcinoma. However, the efficacy of TIL-based therapies still needs more clinical trials to prove. In this proposal, a one-arm, open, multicenter, phaseⅠ/Ⅱ trial was designed to evaluate the efficacy and safety of autologous tumor-infiltrating lymphocytes in treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.
Objective Response Rate
To evaluate the efficacy of TILs in patients with advanced or metastatic refractory malignant gynecological cancer including cervical, ovarian, endometrial and breast carcinoma based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 6 months
Disease Control Rate
To evaluate the efficacy of TILs in patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma based on the disease control rate (DCR) as assessed by the IRC per RECIST v1.1
Time frame: Up to 60 months
Progression-Free Survival
To evaluate the efficacy of TILs in patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma based on the progression-free survival (PFS) as assessed by the IRC per RECIST v1.1
Time frame: Up to 60 months
Overall Survival
To evaluate overall survival (OS) in patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma
Time frame: Up to 60 months
Adverse Events
To characterize the safety profile of TILs in patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma as assessed by incidence of adverse events
Time frame: Up to 60 months
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