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

Shanghai Cancer Hospital, China

Status and phase: Unknown; Phase 2

Conditions: Thymic Epithelial Tumor

Treatments: Drug: rhGM-CSF，Peginterferon alfa-b2，radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT04517539

FUSCC-SGCI002

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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-α2b 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

SBRT+GM-CSF+INF-αb

Experimental group

Description:

Metastasis lesion will be treated with a SBRT of 30Gy/5F from day 1 to day 5 . Injection of Immunological Agenthuman recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle.Subcutaneous injection of Peginterferon alfa-b2(90ug) will be executed in day8. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Injection of Peginterferon alfa-b2(90ug) will be executed in day8 of this cycle.

Treatment:

Drug: rhGM-CSF，Peginterferon alfa-b2，radiation