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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05656222
Other study ID # PKUPH-sarcoma 15
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date December 1, 2024

Study information

Verified date February 2023
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VIA combination treatment
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.

Locations

Country Name City State
China Peking University People's Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate Based on RECIST1.1 criteria, clinical evaluation was done once every 6 weeks 12 weeks
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