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

NCT03011255 | Unknown Phase 2 DMC

• 1 other identifier: HangzhouCH06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms; Esophageal Diseases; Digestive System Diseases

Keywords

Esophageal cancer; Peptide specific CTL; Radiation

Outcome Measures

Primary Outcomes (1)

• Local control

  occurrence of local or regional progression

  two years after enrollment

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  3 months

• Objective response rate as assessed by RECIST criteria

  3 months

• Time to progression

  1 year

• Overall survival

  1 year

Study Arms (1)

peptide specific CTL arm

EXPERIMENTAL

peptide specific CTL, radiation

Biological: peptide specific CTL

Interventions

peptide specific CTL BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shixiu Wu: lead

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of the hospital

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 5, 2017
• Study Start: December 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2019
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)