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

Sponsor
Shanghai Cancer Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05407649
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
95.9
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radiotherapy Combined with GM-CSF
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Radiotherapy Combined with GM-CSF

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).

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Shanghai Cancer Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fan Min, Clinical Professor, Shanghai Cancer Hospital, China
ClinicalTrials.gov Identifier:
NCT05407649
Other Study ID Numbers:
  • FUSCC-SGCI001
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thymoma

Study Results

No Results Posted as of Jun 7, 2022