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Taking people in ChinaPhase 2

Radiation with anlotinib before surgery for soft tissue sarcoma

Tests radiation plus anlotinib before surgery in adults with soft tissue sarcoma.

Key facts

Who runs it
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Where
Beijing, ChinaSee the site
Trial code
Registry title
Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma （SPARE-01）
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
1 May 2020
Expected to end
31 Dec 2027
Type of study
Interventional
Treatments tested
  • Anlotinib hydrochloride
Record updated
4 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with soft tissue sarcoma of the arm, leg or trunk that has not spread. They get radiotherapy with anlotinib and penpulimab before surgery.

Age
Older than 18 years
Sex
All sexes
Disease stage
Soft tissue sarcoma of the trunk or limbs, proven by tissue examination. The team must find that radiotherapy before surgery and surgery that spares the limb are appropriate. No signs of distant spread.
Earlier treatment
No earlier radiation to the same area. No chemotherapy before surgery, given or planned.

Main reasons for not taking part

  • Dermatofibrosarcoma protuberans, desmoid tumours or benign tumours
  • Distant metastases seen on scans
  • Another cancer within the last 5 years (some exceptions)
  • Conditions that rule out anlotinib, such as active bleeding, ulcer, bowel perforation or blockage, or uncontrolled high blood pressure
  • Sarcoma that can be removed with a large operation alone

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • No gross tumor post-resection in other center
  • Previous irradiation to the same area
  • Neoadjuvant chemotherapy given or planned
  • 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
  • Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
  • Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc
  • Benign histology
  • STS can be cured by extensive operation alone
  • Radiological evidence of distant metastases
  • Other contraindications, can't tolerate operation or other treatment needed in this study

Where in China

  • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaContact: Ningning Lu, DoctorTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Anlotinib and Penpulimab armTreatment being tested

    Pre-operative IMRT with concurrent and sequential Anlotinib and Penpulimab

    Treatment: Anlotinib hydrochloride

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Preoperative Intensity-Modulated Radiotherapy (IMRT) Combined With Concurrent Anlotinib Hydrochloride and Penpulimab for Localized Extremity or Trunk Sarcoma
Plain-language title
Radiation with anlotinib before surgery for soft tissue sarcomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 June 2026