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SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer

NCT02545751 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-11-28

No results posted yet for this study

Summary

Patients with esophageal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.

1. To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.
2. To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and thymalfasin for heavily pretreated, metastatic esophageal cancer patients; This study will help find out what effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic esophageal cancer.

Conditions

  • Esophageal Cancer
  • Metastatic Esophageal Cancer
  • Stereotactic Body Radiation Therapy
  • Thymalfasin

Interventions

RADIATION

Stereotactic Body Radiation Therapy

SBRT is given during combined therapy to one of the metastatic lesions, 25Gy in 5 fractions (5Gy per fraction) over one week, conformally to maximally spare normal tissue or organ.

DRUG

Thymalfasin

Thymalfasin treatment is given twice a week with an interval of 3-4 days until progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites.

Sponsors & Collaborators

  • Hangzhou Cancer Hospital

    lead OTHER

Principal Investigators

  • Shixiu Wu, MD · Hangzhou Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545751 on ClinicalTrials.gov