Digestive System Diseases, Esophageal Diseases, Esophageal Neoplasms
Conditions
Keywords
Esophageal cancer, Peptide specific CTL, Radiation
Brief summary
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.
Interventions
BIOLOGICALpeptide 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.
Sponsors
Shixiu Wu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control | two years after enrollment | occurrence of local or regional progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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 | 3 months | — |
| Time to progression | 1 year | — |
| Overall survival | 1 year | — |
Countries
China
Outcome results
None listed