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

Thymic Epithelial Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04517539
• Other study ID #: FUSCC-SGCI002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: December 10, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Cancer Hospital, China
• Contact: MIN FAN
• Phone: +862164175590
• Email: fanming[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: December 10, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age =18 years;

2. Histologically proven Thymic epithelial tumors;

3. Stage IV according to UICC stage system(version 8,2017), at least with two evaluable abscopal lesions (=1cm)(excluding intestinal metastasis);

4. Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);

5. ECOG performance status: 0-1;

6. Life expectancy = 3 months.

7. Adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per µL, platelet concentration of greater than 50 000 per µL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;

8. Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;

9. Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;

10. Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

Exclusion Criteria:

1. Having received immunotherapy within 4 weeks prior to inclusion;

2. Allergic to GM-CSF, INF-a2b or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;

3. receiving treatment of other trials;

4. Any unstable systemic disease, including active infection, symptomatic congestive heart failure,myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease;

5. unwilling to sign consent;

6. Women in pregnancy or lactation;

7. Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Thymic Epithelial Tumor
• Thymus Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University shanghai cancer center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Cancer Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The abscopal effect rate	The proportion of patients with an abscopal response assessed after the initiation of treatment	up to 12 months
Secondary	Progression free survival	From the date of enrollment to the date of progression or death	up to 60 months
Secondary	Overall survival	From the date of enrollment to the date of death or last follow-up	up to 60 months