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Recruiting nowPhase 2Ages 18 Years and up

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT05167994 on ClinicalTrials.gov ↗

Conditions studied

Sarcoma,Soft TissueExtremityTrunkAnlotinibIntensity-modulated RadiotherapyMajor Wound Complications

What it tests

  • Anlotinib hydrochloridedrug

Where it's running1 site

1 international site
  • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China 100021

    Recruiting now
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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.

Updated 2026-06-04 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.