Phase I clinical study of personalized peptide vaccination combined with radiotherapy for advanced hepatocellular carcinoma

World J Gastroenterol. 2017 Aug 7;23(29):5395-5404. doi: 10.3748/wjg.v23.i29.5395.

Abstract

Aim: To assess the efficacy and safety of a new treatment modality, cellular immune therapy based on personalized peptide vaccination (PPV-DC-CTL) combined with radiotherapy, for treating advanced hepatocellular carcinoma (HCC).

Methods: A total of nine patients with advanced HCC were enrolled. Multidisciplinary consultation confirmed that all the patients definitely had no opportunity of surgery, because four patients had multiple liver metastases (the number of liver lesions > 3), one patient had liver metastases and portal vein tumor thrombosis, one patient had lung and bone metastases, two patients had liver and lung metastases and one patient had liver metastasis and peritoneal metastasis. Patients with metastasis were treated with precise radiotherapy combined with PPV-DC-CTL.

Results: Following radiotherapy and one to three cycles of PPV-DC-CTL treatment, AFP levels were significantly decreased in six patients and imaging assessment of the lesions showed a partial response (PR) in three patients and stable disease in the other three patients. The response rate was 33% and disease control rate was 66%. This regimen was found to be safe and well tolerated. None of the patients developed liver or kidney side effects. Only one patient developed grade II bone marrow suppression and the remaining patients had no significant hematological side effects.

Conclusion: Radiotherapy combined with PPV-DC-CTL provides a new therapeutic strategy for patients with advanced HCC, which is well tolerated, safe, feasible and effective.

Keywords: Cytotoxic lymphocytes; Hepatocellular carcinoma; Personalized peptide vaccination; TOMO radiotherapy.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Bone Marrow / drug effects
  • Bone Neoplasms / blood
  • Bone Neoplasms / secondary
  • Bone Neoplasms / therapy*
  • Cancer Vaccines / therapeutic use*
  • Carcinoma, Hepatocellular / blood
  • Carcinoma, Hepatocellular / pathology
  • Carcinoma, Hepatocellular / therapy*
  • Combined Modality Therapy / adverse effects
  • Combined Modality Therapy / methods
  • Female
  • Humans
  • Liver Neoplasms / blood
  • Liver Neoplasms / pathology
  • Liver Neoplasms / therapy*
  • Lung Neoplasms / blood
  • Lung Neoplasms / secondary
  • Lung Neoplasms / therapy*
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Peptides / therapeutic use*
  • Peritoneal Neoplasms / blood
  • Peritoneal Neoplasms / secondary
  • Peritoneal Neoplasms / therapy*
  • Portal Vein / pathology
  • Precision Medicine / adverse effects
  • Precision Medicine / methods*
  • Radiotherapy / adverse effects
  • Radiotherapy / methods
  • Vaccination / adverse effects
  • Vaccination / methods*
  • Venous Thrombosis / etiology
  • Venous Thrombosis / therapy
  • alpha-Fetoproteins / analysis

Substances

  • Cancer Vaccines
  • Peptides
  • alpha-Fetoproteins