Trial | NCT03011255  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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.
Study Started
Dec 31
2016
Primary Completion
Aug 31
2017
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Aug 07
2017

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.

peptide specific CTL arm Experimental

peptide specific CTL, radiation

Criteria 

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
No Results Posted