Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05167994

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Ning-Ning Lu, M.D.

PRINCIPAL_INVESTIGATOR

Ningning Lu, Doctor

CONTACT

[email protected]

+86 01087787630

Sheng-Ji Yu, M.D

PRINCIPAL_INVESTIGATOR

Shu-Lian Wang, M.D

PRINCIPAL_INVESTIGATOR

Shu-Lian Wang, M.D.

CONTACT

[email protected]

+86 01087788280

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anlotinib hydrochloride

Drug

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

Primary outcomes

  1. Major wound complications

    Time frame: 4-months post-surgery

Secondary outcomes

  1. Acute and late toxicities

    Time frame: acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  2. Quality of Life

    Time frame: pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up

    Evaluate quality of life by QOL questionnaires at different time points

  3. Extremity function

    Time frame: pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up

    Evaluate quality of life by MSTS forms at different time points

  4. Pathological remission rate

    Time frame: 2 weeks after operation

    evaluate the tumor remission rate microscopically

  5. Local control

    Time frame: 2-year

  6. Overall Survival

    Time frame: 2-year

Study contacts

Contact information is provided by the study sponsor or research team.

Ning-Ning Lu

CONTACT

[email protected]

+868611804268

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Beijing Jishuitan Hospital

Registry information

Official study title

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

Acronym: SPARE-01

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2021
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.