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Recruiting NCT05167994

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

Phase II Interventional Sarcoma,Soft Tissue Extremity Trunk Anlotinib

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anlotinib hydrochloride.
Who it may be relevant to
Registry conditions: Sarcoma,Soft Tissue, Extremity, Trunk, Anlotinib. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Preoperative Intensity-Modulated Radiotherapy (IMRT) Combined With Concurrent Anlotinib Hydrochloride and Penpulimab for Localized Extremity or Trunk Sarcoma

Overview

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.

Interventions

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

Primary outcome measures

  • Major wound complications [Time frame: 4-months post-surgery]
Secondary outcome measures (6)
  • Acute and late toxicities [Time frame: acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months]
  • Quality of Life [Time frame: pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up]
  • Extremity function [Time frame: pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up]
  • Pathological remission rate [Time frame: 2 weeks after operation]
  • Local control [Time frame: 2-year]
  • Overall Survival [Time frame: 2-year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT05167994 · NCC2333

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗