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

Thymoma Clinical Trial

Official title:

Abscopal Effect and Safety of Recurrent and Refractory Advanced Thymic Epithelial Tumours Treated With Combined Therapy of Local Radiotherapy and Granulocyte-macrophage Colony-stimulating Factor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407649
• Other study ID #: FUSCC-SGCI001
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2016
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2022
• Source: Shanghai Cancer Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-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;

Related Conditions & MeSH terms

• Thymoma

Intervention

Radiation:
• 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).

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; The proportion of patients with an abscopal response assessed after the initiation of treatment	up to 12 months