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Abscopal Effect of SBRT in Combination With rhGM-CSF and INF-α 2b for Metastatic Thymic Epithelial Tumors

NCT04517539 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-08-18

No results posted yet for this study

Summary

The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and Peginterferon alfa-2b is safe, effective in the treatment of patients with metastatic thymic epithelial tumors.

Conditions

  • Thymic Epithelial Tumor

Interventions

DRUG

rhGM-CSF，Peginterferon alfa-b2，radiation

Radiation: If there are two measurable lesions totally, One lesion received radiotherapy for 30 Gy in 5 fractions and rested for one week; If there are three measurable lesions totally, two lesion received radiotherapy for 30 Gy in 5 fractions separately. drug: Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy. Peginterferon alfa-b2 90 ug in d8 in each cycle. And the 1 month after the end of all radiotherapy courses, 4 weeks as a course of treatment, once per course of treatment, each dose is 90μg until desease progress.

Sponsors & Collaborators

  • Shanghai Cancer Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-01
Completion
2022-12-10

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 NCT04517539 on ClinicalTrials.gov