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

Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Digestive System Diseases; Esophageal Neoplasms; Esophageal Diseases
• Intervention / Treatment: Biological: peptide specific CTL

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Hangzhou Cancer Hospital
      • Contact: Shixiu Wu, MD; Phone Number: +8657186826086; Email: wushixiu@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: peptide specific CTL arm; peptide specific CTL, radiation	Biological: peptide 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control	occurrence of local or regional progression	two years after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		1 year
Time to progression		1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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	3 months
Objective response rate as assessed by RECIST criteria		3 months

Collaborators and Investigators

• Sponsor: Shixiu Wu

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Esophageal cancer; Radiation; Peptide specific CTL
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Neoplasms; Esophageal Diseases
• Other Study ID Numbers: HangzhouCH06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO