Irinotecan and Anlotinib for Epithelioid Sarcoma

Sponsor

Peking University People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05656222

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Objective Response Overall Survival	Drug: VIA combination treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Actual Primary Completion Date :

Oct 1, 2022

Actual Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VIA treatment Group	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.

Arm

Intervention/Treatment

Experimental: VIA treatment Group

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.

Outcome Measures

Primary Outcome Measures

Objective Response Rate [12 weeks]
Based on RECIST1.1 criteria, clinical evaluation was done once every 6 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing		China

Sponsors and Collaborators

Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xie Lu, Musculoskeletal Tumor Center, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT05656222

Other Study ID Numbers:

PKUPH-sarcoma 15

First Posted:

Dec 19, 2022

Last Update Posted:

Dec 19, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xie Lu, Musculoskeletal Tumor Center, Peking University People's Hospital

Additional relevant MeSH terms:

Sarcoma

Study Results

No Results Posted as of Dec 19, 2022