Back to resultsIrinotecan and Anlotinib for Epithelioid Sarcoma
Primary Purpose
Objective Response, Overall Survival
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
VIA combination treatment
Sponsored by
About this trial
This is an interventional treatment trial for Objective Response focused on measuring Epithelioid sarcoma, systemic treatment, objective response, toxicity
Eligibility Criteria
Inclusion Criteria: (1) Grade 2 or 3 ES confirmed histologically using the American Joint Committee on Cancer (AJCC) system ; (2) patients presented with measurable lesions using the Response Evaluation Criteria In Solid Tumors (RECIST1.1) and were not amenable to surgical resection or radiotherapy; (3) primary or secondary metastatic disease; (4) received more than two courses of the VIA regimen; (5) no concurrent treatment was given while on the VIA regimen; (6) follow-up information and evaluation after chemotherapy were available. Exclusion Criteria: less than 4 cycles of treatment; medical records were not complete.
Sites / Locations
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VIA treatment Group
Arm Description
Outcomes
Primary Outcome Measures
Objective Response Rate
Based on RECIST1.1 criteria, clinical evaluation was done once every 6 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT05656222
First Posted
December 9, 2022
Last Updated
February 14, 2023
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05656222
Brief Title
Irinotecan and Anlotinib for Epithelioid Sarcoma
Official Title
A Retrospective Study Investigating the Combination of Irinotecan, Vincristine and Anlotinib for Epithelioid Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Check the IRB again
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Epithelioid sarcoma is a rare soft tissue sarcoma characterized by SMARCB1/INI1 deficiency. Much attention has been paid to the selective EZH2 inhibitor tazemetostat, where other systemic treatments are generally ignored. To explore alternative treatment options, we studied the effects of irinotecan-based chemotherapy in a series of epithelioid sarcoma patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Objective Response, Overall Survival
Keywords
Epithelioid sarcoma, systemic treatment, objective response, toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIA treatment Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
VIA combination treatment
Intervention Description
a 90-minute intravenous infusion of irinotecan at a dose of 50 mg/m2/d for 5 days every 3 weeks, vincristine given at a dose of 1.4 mg/m2 (maximum 2 mg) on days 1 and 8, and oral administration of Anlotinib once daily on days 1-14 within a 21-day cycle.
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
Based on RECIST1.1 criteria, clinical evaluation was done once every 6 weeks
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) Grade 2 or 3 ES confirmed histologically using the American Joint Committee on Cancer (AJCC) system ;
(2) patients presented with measurable lesions using the Response Evaluation Criteria In Solid Tumors (RECIST1.1) and were not amenable to surgical resection or radiotherapy;
(3) primary or secondary metastatic disease;
(4) received more than two courses of the VIA regimen;
(5) no concurrent treatment was given while on the VIA regimen;
(6) follow-up information and evaluation after chemotherapy were available.
Exclusion Criteria:
less than 4 cycles of treatment;
medical records were not complete.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Irinotecan and Anlotinib for Epithelioid Sarcoma
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