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

Primary Purpose

Esophageal Neoplasms, Esophageal Diseases, Digestive System Diseases

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

peptide specific CTL

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Esophageal cancer, Peptide specific CTL, Radiation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Hangzhou Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

peptide specific CTL arm

Arm Description

peptide specific CTL, radiation

Outcomes

Primary Outcome Measures

Local control

occurrence of local or regional progression

Secondary Outcome Measures

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

Objective response rate as assessed by RECIST criteria

Time to progression

Overall survival

Full Information

NCT ID

NCT03011255

First Posted

December 28, 2016

Last Updated

August 3, 2017

Sponsor

Shixiu Wu

1. Study Identification

Unique Protocol Identification Number

NCT03011255

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shixiu Wu

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Neoplasms, Esophageal Diseases, Digestive System Diseases

Keywords

Esophageal cancer, Peptide specific CTL, Radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

peptide specific CTL arm

Arm Type

Experimental

Arm Description

peptide specific CTL, radiation

Intervention Type

Biological

Intervention Name(s)

peptide specific CTL

Intervention Description

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 Measure Information:

Title

Local control

Description

occurrence of local or regional progression

Time Frame

two years after enrollment

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

3 months

Title

Objective response rate as assessed by RECIST criteria

Time Frame

3 months

Title

Time to progression

Time Frame

1 year

Title

Overall survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Hangzhou Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shixiu Wu, MD

Phone

+8657186826086

wushixiu@medmail.com.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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