Abscopal Effect of Radiotherapy in Combination With rhGM-CSF for Advanced Thymic Epithelial Tumours

NCT ID: NCT05407649

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2023-12-30

Brief Summary

The purpose of this study is to determine whether radiotherapy (RT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of patients with advanced thymic epithelial tumours.

Conditions

Thymoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy Combined with GM-CSF

Group Type: EXPERIMENTAL

Radiotherapy Combined with GM-CSF

Intervention Type: RADIATION

Patients with stable or progressing metastatic thymic epithelial tumours, with at least two distinct measurable sites of disease, were treated with concurrent radiotherapy (35 Gy in ten fractions or 60Gy in 30 fractions) to one metastatic site and granulocyte-macrophage colony-stimulating factor (125 μg/m(2) subcutaneously injected daily for 2 weeks, starting during the second week of radiotherapy).

Interventions

Radiotherapy Combined with GM-CSF

Patients with stable or progressing metastatic thymic epithelial tumours, with at least two distinct measurable sites of disease, were treated with concurrent radiotherapy (35 Gy in ten fractions or 60Gy in 30 fractions) to one metastatic site and granulocyte-macrophage colony-stimulating factor (125 μg/m(2) subcutaneously injected daily for 2 weeks, starting during the second week of radiotherapy).

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years;

2. Histologically proven thymic epithelial tumours；

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Cancer Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Fan Min

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Min Fan, MD

Role: primary

fanming@fudan.edu.cn

18017312298

Other Identifiers

FUSCC-SGCI001

Identifier Type: -

Identifier Source: org_study_id