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

NCT04517539 | Unknown Phase 2

• 1 other identifier: FUSCC-SGCI002
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The abscopal effect rate

  The proportion of patients with an abscopal response assessed after the initiation of treatment

  up to 12 months

Secondary Outcomes (2)

• Progression free survival

  up to 60 months

• Overall survival

  up to 60 months

Study Arms (1)

SBRT+GM-CSF+INF-αb

EXPERIMENTAL

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.

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

Interventions

rhGM-CSF，Peginterferon alfa-b2，radiation DRUG

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.

SBRT+GM-CSF+INF-αb

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Histologically proven Thymic epithelial tumors；
• Stage IV according to UICC stage system(version 8,2017), at least with two evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）;
• Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);
• ECOG performance status: 0-1;
• Life expectancy ≥ 3 months.
• 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;
• Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;
• Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;
• Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

You may not qualify if:

• 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;
• receiving treatment of other trials;
• 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;
• unwilling to sign consent;
• Women in pregnancy or lactation;
• Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

Sponsors & Collaborators

• Shanghai Cancer Hospital, China: lead

Study Sites (1)

Fudan University shanghai cancer center

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Thymic epithelial tumor

Central Study Contacts

MIN FAN

CONTACT

+862164175590; fanming@fudan.edu.cn

JIAYAN CHEN

CONTACT

+8618121299483; chenjiayan2008@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 18, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 10, 2022
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

CN (1)