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

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Neoplasms, Esophageal Diseases, Digestive System Diseases

Intervention / Treatment
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* Biological: peptide specific CTL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have unresectable, locally advanced, recurrent disease of esophageal cancer. Histologically confirmed cancer of the esophagus. measurable disease by CT scan ECOG performance status of 0 to 2 Expected survival of at least 3months 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 Able and willing to give valid written informed consent Exclusion Criteria: Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception) Breastfeeding Active or uncontrolled infection Prior chemotherapy, radiation therapy or immunotherapy Concurrent treatment with steroid or immunosuppressing agent Patient with peptic ulcer disease Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ Disease to the central nervous system Decision of unsuitableness by principal investigator or physician-in-charge

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peptide specific CTL arm<br>peptide specific CTL, radiation | Biological: peptide specific CTL<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | occurrence of local or regional progression | two years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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 | 3 months | 
| Objective response rate as assessed by RECIST criteria |  | 3 months | 
| Time to progression |  | 1 year | 
| Overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal cancer, Peptide specific CTL, Radiation