Clinical trial NCT03011255: Combination of Radiation Therapy and Peptide Specific CTL Therapy in Treating Patients With Esophageal Cancer
Official title: Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Neoplasms
Esophageal Diseases
Digestive System Diseases
Keywords: Esophageal cancer
Peptide specific CTL
Radiation
Lead sponsor: Hangzhou Cancer Hospital
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Local control
timeFrame: two years after enrollment
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 3 months
measure: Objective response rate as assessed by RECIST criteria
timeFrame: 3 months
measure: Time to progression
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
References: