Combination of Radiation Therapy and Peptide Specific CTL Therapy in Treating Patients With Esophageal Cancer

Overview

Immunotherapy is now considered to be one of promising approaches for treating cancer. Radiation therapy has been to be a cornerstone treatment for unresectable advanced esophageal cancer. Radiation-induced mutation genes were identified as new sources of tumor associated antigens using exon sequencing and peptide microarray technologies. Epitope peptides for these targets are able to induce peptide specific cytotoxic T lymphocytes (CTL). In this clinical trial, investigators evaluate the efficacy and safety of peptide specific CTL therapy in combination with radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Full Title of Study: “Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2017

Interventions

  • Biological: peptide specific CTL
    • Radiation: RT to 60 Gy, 5 x per week,for 6 weeks Biological: Peptide specific CTL Peptide specific CTL will be administered by intravenous injection on day 28 of radiation.

Arms, Groups and Cohorts

  • Experimental: peptide specific CTL arm
    • peptide specific CTL, radiation

Clinical Trial Outcome Measures

Primary Measures

  • Local control
    • Time Frame: two years after enrollment
    • occurrence of local or regional progression

Secondary Measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    • Time Frame: 3 months
    • Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0
  • Objective response rate as assessed by RECIST criteria
    • Time Frame: 3 months
  • Time to progression
    • Time Frame: 1 year
  • Overall survival
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

1. Patients must have unresectable, locally advanced, recurrent disease of esophageal cancer. Histologically confirmed cancer of the esophagus. 2. measurable disease by CT scan 3. ECOG performance status of 0 to 2 4. Expected survival of at least 3months 5. Laboratory values as follow:

  • Absolute neutrophil count (ANC) ≥ 1.5×109 – White blood cell count ≥ 3×109/L – Platelets ≥ 100×109/L – Haemoglobin (Hb) ≥ 10g/dL (patients'Hb should be corrected to >10g/dL before treatment) – Adequate liver function (within 1 week prior to randomization) – Serum bilirubin ≤ 1.5× ULN – Alanine aminotransferase/aspartate transaminase (ALT / AST) ≤ 2.5× ULN – Alkaline phosphatase (ALP) ≤ 3× ULN 6. Able and willing to give valid written informed consent Exclusion Criteria:

1. Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception) 2. Breastfeeding 3. Active or uncontrolled infection 4. Prior chemotherapy, radiation therapy or immunotherapy 5. Concurrent treatment with steroid or immunosuppressing agent 6. Patient with peptic ulcer disease 7. Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ 8. Disease to the central nervous system 9. Decision of unsuitableness by principal investigator or physician-in-charge

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shixiu Wu
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Shixiu Wu, director of the hospital – Hangzhou Cancer Hospital

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