Irinotecan and Anlotinib for Epithelioid Sarcoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Objective Response Overall Survival

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VIA treatment Group

Group Type EXPERIMENTAL

VIA combination treatment

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.