🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05167994
Recruiting Phase 2

Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma (SPARE-01)

NCT05167994 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 2
Started
2020-05-01
Last updated
2026-06-04

Condition(s) studied

Sarcoma,Soft TissueExtremityTrunkAnlotinibIntensity-modulated RadiotherapyMajor Wound Complications

Investigational drug(s) / intervention(s)

Anlotinib hydrochloride

Anlotinib hydrochloride: Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT

Study 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 and Penpulimab for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting

More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05167994 on ClinicalTrials.gov ↗ ← All trials in China