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.

Highlights

  • Hepatocellular carcinoma (HCC) is one of the most prevalent and lethal malignancies worldwide

  • After a median follow-up of 14 months, 15 patients (100%) were alive; and 12 patients (80%) showed no evidence of disease, 3 patients 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 tumor-infiltrating lymphocytes (TIL) could be successfully performed with low toxicity, would serve as a novel treatment modality for patients with hepatocellular carcinoma (HCC)

  • Fifteen patients were enrolled in the study, and all patients presented with HCC without distant organ metastasis at diagnosis

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Summary

Introduction

Hepatocellular carcinoma (HCC) is one of the most prevalent and lethal malignancies worldwide. It is the fifth most common cancer and ranks as the third leading cause of cancer-related deaths. In China, current treatment options for early-stage HCC include surgery, transarterial chemoembolization (TACE) and molecular targeted therapy. The overall outcome of such efforts towards HCC is disappointing, with only 10–20% of tumors resectable at the time of diagnosis, and the five-year survival is poor compared with other gastrointestinal malignancies [1, 2]. Patients with advanced HCC did not have very much therapeutic options. A major milestone in the treatment for this disease was the clinical use of sorafenib. A multikinase inhibitor targeting the Raf serine/

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