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

Phase 2

• Conditions: Esophageal Diseases; Digestive System Diseases; Esophageal Neoplasms
• Interventions: Biological: peptide specific CTL

• Registration Number: NCT03011255
• Lead Sponsor: Shixiu Wu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
peptide specific CTL arm	peptide specific CTL	peptide specific CTL, radiation

Primary Outcome Measures

Name	Time	Method
Local control	two years after enrollment	occurrence of local or regional progression

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year
Time to progression	1 year
Objective response rate as assessed by RECIST criteria	3 months
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

Trial Locations

Locations (1)

Hangzhou Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China