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Trial record 54 of 6670 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

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.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Esophageal Diseases Digestive System Diseases Biological: peptide specific CTL Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer
Study Start Date : December 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Local control [ Time Frame: two years after enrollment ]
    occurrence of local or regional progression


Secondary Outcome Measures :
  1. 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

  2. Objective response rate as assessed by RECIST criteria [ Time Frame: 3 months ]
  3. Time to progression [ Time Frame: 1 year ]
  4. Overall survival [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011255


Locations
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China, Zhejiang
Hangzhou Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Shixiu Wu, MD    +8657186826086    wushixiu@medmail.com.cn   
Sponsors and Collaborators
Shixiu Wu

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Responsible Party: Shixiu Wu, director of the hospital, Hangzhou Cancer Hospital
ClinicalTrials.gov Identifier: NCT03011255     History of Changes
Other Study ID Numbers: HangzhouCH06
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shixiu Wu, Hangzhou Cancer Hospital:
Esophageal cancer
Peptide specific CTL
Radiation
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Diseases
Esophageal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms