Irinotecan and Anlotinib for Epithelioid Sarcoma

Overall Survival Clinical Trial

Official title:

A Retrospective Study Investigating the Combination of Irinotecan, Vincristine and Anlotinib for Epithelioid Sarcoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05656222
• Other study ID #: PKUPH-sarcoma 15
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Objective Response
• Overall Survival
• Sarcoma

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