Background: Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients. TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer. Objective: To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor. Eligibility: Adults aging 18-75 with advanced solid tumor. Design: 1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests. 2. Freshly resected patient tumors were dissected by the surgeon. 3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded. 4. At last TIL cells will be re-infused into the patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
On day 0, all patients will receive autologous tumor-infiltrating lymphocyte cells administered.
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
Nanjing Jinling Hospital
Nanjing, Jiangsu, China
Wowen's hospital, School of medicine, Zhejiang University
Hangzhou, Zhejiang, China
Safety of TIL
The safety of TIL will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase.
Time frame: Day 0 - Day 730
Overall Response Rate (ORR)
To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 and iRECIST as assessed by the investigator.
Time frame: Day 0 - Day 730
Duration of Response (DOR)
To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 and iRECIST as assessed by the investigator until disease progression or death due to any cause.
Time frame: Day 0 - Day 730
Disease Control Rate (DCR)
To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) per RECIST v1.1 and iRECIST as assessed by the investigator.
Time frame: Day 0 - Day 730
Progression free survival (PFS)
To evaluate the time from the date of TIL infusion until disease progression per RECIST v1.1 and iRECIST as assessed by the investigator or death due to any cause.
Time frame: Day 0 - Day 730
Overall survival (OS)
To evaluate the time from the date of TIL infusion to death due to any cause.
Time frame: Day 0 - Day 730
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