NCT05167994RecruitingPhase 2
Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma （SPARE-01）
Preoperative Intensity-Modulated Radiotherapy (IMRT) Combined With Concurrent Anlotinib Hydrochloride and Penpulimab for Localized Extremity or Trunk Sarcoma
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 2 Dec 2021
- Start date
- 1 May 2020
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Sarcoma
- NCT number
- NCT05167994
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 May 2020 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No gross tumor post-resection in other center.
- Previous irradiation to the same area
- Neoadjuvant chemotherapy given or planned.
Other illness
- 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)
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.