title: A phase I clinical trial utilizing autologous tumor-infiltrating lymphocytes in patients with primary hepatocellular carcinoma.
abstract: This report describes an ongoing Phase I clinical trial testing the safety of adoptive cell therapy (ACT) using autologous tumor-infiltrating lymphocytes (TIL) in patients with primary hepatocellular carcinoma (HCC). Fifteen HCC patients were treated with their activated and expanded TILs following tumor resection. From a total of 17 patients with HCC, TIL were successfully expanded from 15 patients (88%), whereas two patients showed minimal or no expansion of TIL. Transient increase in the frequency of T cells was observed after adoptive transfer who was found only associated with grade I flu-like symptoms and malaise. After a median follow-up of 14 months, 15 patients (100%) were alive; and 12 patients (80%) showed no evidence of disease, 3 patients (patient 1,11,12) had tumor recurrence. The time to the diagnosis of tumor recurrence following therapy ranged from 105 to 261 days. These results indicate that immunotherapy with activated and expanded autologous TIL could be successfully performed with low toxicity, thus would serve as a novel treatment modality for patients with HCC.
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Shan-Shan
authors.initials: SS
authors.lastname: Jiang
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Tang
authors.affiliation: Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Yao-Jun
authors.initials: YJ
authors.lastname: Zhang
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: D-Sheng
authors.initials: DS
authors.lastname: Weng
authors.affiliation: Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Zhong-Guo
authors.initials: ZG
authors.lastname: Zhou
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Ke
authors.initials: K
authors.lastname: Pan
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Qiu-Zhong
authors.initials: QZ
authors.lastname: Pan
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Qi-Jing
authors.initials: QJ
authors.lastname: Wang
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Liu
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Jia
authors.initials: J
authors.lastname: He
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Jing-Jing
authors.initials: JJ
authors.lastname: Zhao
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Jiang
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Min-Shan
authors.initials: MS
authors.lastname: Chen
authors.affiliation: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, USA.
authors.forename: Alfred E
authors.initials: AE
authors.lastname: Chang
authors.affiliation: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, USA.
authors.forename: Qiao
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Jian-Chuan
authors.initials: JC
authors.lastname: Xia
mesh_terms: D000328:Adult; D000368:Aged; D015496:CD4-Positive T-Lymphocytes / Q000378:metabolism / Q000637:transplantation; D018414:CD8-Positive T-Lymphocytes / Q000378:metabolism / Q000637:transplantation; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D016207:Cytokines / Q000378:metabolism; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000009:adverse effects / Q000379:methods*; D007970:Leukopenia / Q000209:etiology; D008113:Liver Neoplasms / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D016246:Lymphocytes, Tumor-Infiltrating / Q000378:metabolism / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009503:Neutropenia / Q000209:etiology; D015996:Survival Rate; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D016207:Cytokines
keywords: adoptive cell therapy; autologous tumor-infiltrating lymphocytes; primary hepatocellular carcinoma