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

Phase 2

• Conditions: Thymoma
• Interventions: Radiation: Radiotherapy Combined with GM-CSF

• Registration Number: NCT05407649
• Lead Sponsor: Shanghai Cancer Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2022-05-30
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy Combined with GM-CSF	Radiotherapy Combined with GM-CSF	-

Primary Outcome Measures

Name	Time	Method
The abscopal effect rate	up to 12 months	The proportion of patients with an abscopal response assessed after the initiation of treatment; The proportion of patients with an abscopal response assessed after the initiation of treatment

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China