NCT01691664

Brief Summary

Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

9.3 years

First QC Date

September 18, 2012

Last Update Submit

October 31, 2019

Conditions

Esophageal Cancer

Keywords

Esophageal CancerDC-CIKimmunotherapycellular therapyradiation therapy

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    4 years

Secondary Outcomes (1)

  • quality of life

    Initial assessment → months 1,3,6 and 12

Other Outcomes (1)

  • Immunological assessment

    Initial assessment, months 1,3,6and 12

Study Arms (2)

Only radiation therapy

ACTIVE COMPARATOR

Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Radiation: Only radiation therapy

Radiation therapy plus DC-CIK cellular therapy

EXPERIMENTAL

Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. DC-CIK cellular therapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before radiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the radiation intermittent period.

Other: Radiation therapy plus DC-CIK cellular therapy

Interventions

Only radiation therapyRADIATION

Patients only radiation therapy after surgery

Only radiation therapy
Radiation therapy plus DC-CIK cellular therapyOTHER

Patients receive radiation therapy plus DC-CIK cellular therapy after surgery

Radiation therapy plus DC-CIK cellular therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cytologically or histologically confirmed esophageal carcinoma
  • Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
  • Prior en bloc resection, with curative intent, of all known tumor
  • No metastatic disease
  • Age: \> 18
  • Karnofsky performance status ≥ 70
  • At least 3 weeks since prior surgery
  • Normal functions of heart, lung, liver, kidney and bone marrow
  • Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
  • All patients must be evaluated by a radiation oncologist prior to enrollment to ensure patient is appropriate for radiotherapy
  • Informed consent signed

You may not qualify if:

  • Patients with metastatic disease.
  • Patients who are pregnant or nursing.
  • Patients with poor bone marrow, liver and kidney functions, which would make radiation therapy intolerable
  • Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jun Ren, MD, PhD

    Capital Medical University Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ren, MD,PhD

CONTACT

86-10-63926317renjun9688@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Capital Medical University Cancer Center

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 25, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

CN(1)