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

NCT05407649 | Unknown Phase 2 DMC

• 1 other identifier: FUSCC-SGCI001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Radiotherapy Combined with GM-CSF

EXPERIMENTAL

Radiation: Radiotherapy Combined with GM-CSF

Interventions

Radiotherapy Combined with GM-CSF 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).

Radiotherapy Combined with GM-CSF

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• Histologically proven thymic epithelial tumours；
• 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;

Sponsors & Collaborators

• Shanghai Cancer Hospital, China: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Thymoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 7, 2022
• Study Start: January 1, 2016
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)