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

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ClinicalTrials.gov Identifier: NCT03011255
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Shixiu Wu, Hangzhou Cancer Hospital

Tracking Information
First Submitted Date  ICMJE December 28, 2016
First Posted Date  ICMJE January 5, 2017
Last Update Posted Date August 7, 2017
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
Local control [ Time Frame: two years after enrollment ]
occurrence of local or regional progression
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03011255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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
  • Objective response rate as assessed by RECIST criteria [ Time Frame: 3 months ]
  • Time to progression [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Radiation Therapy and Peptide Specific CTL Therapy in Treating Patients With Esophageal Cancer
Official Title  ICMJE Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Neoplasms
  • Esophageal Diseases
  • Digestive System Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: peptide specific CTL arm
peptide specific CTL, radiation
Intervention: Biological: peptide specific CTL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03011255
Other Study ID Numbers  ICMJE HangzhouCH06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shixiu Wu, Hangzhou Cancer Hospital
Study Sponsor  ICMJE Shixiu Wu
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hangzhou Cancer Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP