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RECRUITINGPHASE2

Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma （SPARE-01）

Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma

NCT05167994•Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age older than 18-yo
•Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
•ECOG 0-3
•Histology reviewed by reference pathologist
•Lesion can be assessed
•Can tolerate radiotherapy and Anlotinib
•Agree contraception.
•Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

Exclusion Criteria

•No gross tumor post-resection in other center.
•Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
•Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
•Benign histology
•Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
•STS can be cured by extensive operation alone.
•Previous irradiation to the same area
•Radiological evidence of distant metastases
•Other contraindications, can't tolerate operation or other treatment needed in this study.
•Neoadjuvant chemotherapy given or planned.

Locations (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 1, 2020

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

December 11, 2025

Enrollment

ESTIMATED participants

Conditions

Sarcoma,Soft TissueExtremityTrunkAnlotinibIntensity-modulated RadiotherapyMajor Wound Complications

Interventions

Anlotinib hydrochloride

DRUG

Contacts

Ning-Ning Lu

CONTACT

+868611804268 Ning-Ning.Lu@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma （SPARE-01）

Inclusion Criteria

Exclusion Criteria

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