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Irinotecan and Anlotinib for Epithelioid Sarcoma
A Retrospective Study Investigating the Combination of Irinotecan, Vincristine and Anlotinib for Epithelioid Sarcoma
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 16, 2023
February 1, 2023
3.2 years
December 9, 2022
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
Based on RECIST1.1 criteria, clinical evaluation was done once every 6 weeks
12 weeks
Study Arms (1)
VIA treatment Group
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- less than 4 cycles of treatment;
- medical records were not complete.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, China
Related Publications (1)
Xie L, Sun X, Xu J, Liang X, Liu K, Sun K, Yang R, Tang X, Guo W. The efficacy and safety of vincristine, irinotecan and anlotinib in Epithelioid Sarcoma. BMC Cancer. 2024 Feb 3;24(1):172. doi: 10.1186/s12885-024-11921-7.
PMID: 38310286DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Musculoskeletal Tumor Center
Study Record Dates
First Submitted
December 9, 2022
First Posted
December 19, 2022
Study Start
August 1, 2021
Primary Completion
October 1, 2024
Study Completion
December 1, 2024
Last Updated
February 16, 2023
Record last verified: 2023-02