Combination of Radiation Therapy and Peptide Specific CTL... | NCT03011255

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

NCT03011255

Sponsor

Shixiu Wu

Status

Unknown status

Last Update Posted

Aug 7, 2017Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Esophageal Neoplasms
Esophageal Diseases
Digestive System Diseases

Interventions

peptide specific CTL

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Dec 28, 2016

First Submission Date that Met QC Criteria

Jan 3, 2017

First Posted Date

Jan 5, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2017

Last Update Posted Date

Aug 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
peptide specific CTL arm	Experimental	peptide specific CTL, radiation	Biological: peptide specific CTL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
peptide specific CTL	Biological	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D004938	Esophageal Neoplasms
D004935	Esophageal Diseases
D004066	Digestive System Diseases