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

Shixiu Wu

Status and phase: Unknown; Phase 2

Conditions: Digestive System Diseases; Esophageal Diseases; Esophageal Neoplasms

Treatments: Biological: peptide specific CTL

Study type: Interventional

Funder types: Other

Identifiers

NCT03011255

HangzhouCH06

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

peptide specific CTL arm

Experimental group

Description:

peptide specific CTL, radiation

Treatment:

Biological: peptide specific CTL