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Abscopal Effect of SBRT in Combination With rhGM-CSF and INF-α 2b for Metastatic Thymic Epithelial Tumors

Primary Purpose

Thymic Epithelial Tumor

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

rhGM-CSF，Peginterferon alfa-b2，radiation

About this trial

This is an interventional treatment trial for Thymic Epithelial Tumor

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 years;
Histologically proven Thymic epithelial tumors；
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.

Exclusion Criteria:

Having received immunotherapy within 4 weeks prior to inclusion;
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;
Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

Sites / Locations

Fudan University shanghai cancer center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT+GM-CSF+INF-αb

Arm Description

Metastasis lesion will be treated with a SBRT of 30Gy/5F from day 1 to day 5 . Injection of Immunological Agenthuman recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle.Subcutaneous injection of Peginterferon alfa-b2(90ug) will be executed in day8. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Injection of Peginterferon alfa-b2(90ug) will be executed in day8 of this cycle.

Outcomes

Primary Outcome Measures

The abscopal effect rate

The proportion of patients with an abscopal response assessed after the initiation of treatment

Secondary Outcome Measures

Progression free survival

From the date of enrollment to the date of progression or death

Overall survival

From the date of enrollment to the date of death or last follow-up

Full Information

NCT ID

NCT04517539

First Posted

August 16, 2020

Last Updated

August 16, 2020

Sponsor

Shanghai Cancer Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT04517539

Brief Title

Abscopal Effect of SBRT in Combination With rhGM-CSF and INF-α 2b for Metastatic Thymic Epithelial Tumors

Official Title

Abscopal Effect of SBRT in Combination With rhGM-CSF and INF-α 2b for Metastatic Thymic Epithelial Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2020 (Anticipated)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Cancer Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and Peginterferon alfa-2b is safe, effective in the treatment of patients with metastatic thymic epithelial tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thymic Epithelial Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SBRT+GM-CSF+INF-αb

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

rhGM-CSF，Peginterferon alfa-b2，radiation

Intervention Description

Radiation: If there are two measurable lesions totally, One lesion received radiotherapy for 30 Gy in 5 fractions and rested for one week; If there are three measurable lesions totally, two lesion received radiotherapy for 30 Gy in 5 fractions separately. drug: Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy. Peginterferon alfa-b2 90 ug in d8 in each cycle. And the 1 month after the end of all radiotherapy courses, 4 weeks as a course of treatment, once per course of treatment, each dose is 90μg until desease progress.

Primary Outcome Measure Information:

Title

The abscopal effect rate

Description

The proportion of patients with an abscopal response assessed after the initiation of treatment

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Progression free survival

Description

From the date of enrollment to the date of progression or death

Time Frame

up to 60 months

Title

Overall survival

Description

From the date of enrollment to the date of death or last follow-up

Time Frame

up to 60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years; Histologically proven Thymic epithelial tumors； 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. Exclusion Criteria: Having received immunotherapy within 4 weeks prior to inclusion; 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; Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MIN FAN

Phone

+862164175590

fanming@fudan.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

JIAYAN CHEN

Phone

+8618121299483

chenjiayan2008@126.com

Facility Information:

Facility Name

Fudan University shanghai cancer center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Abscopal Effect of SBRT in Combination With rhGM-CSF and INF-α 2b for Metastatic Thymic Epithelial Tumors

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