Preoperative intensity-modulated radiotherapy with concurrent anlotinib for localized extremity and trunk soft tissue sarcoma
Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma
This test combines preoperative IMRT and the drug anlotinib to see if it improves outcomes for adults with primary soft tissue sarcoma of the arms, legs, or trunk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | Anlotinib, chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05167994 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2 interventional trial giving anlotinib hydrochloride concurrently with preoperative intensity-modulated radiotherapy (IMRT) for primary truncal or extremity soft tissue sarcoma. The protocol tracks safety, tumor response, local control, quality of life, and limb function after the combined treatment. Investigators will also explore whether anlotinib enhances radiosensitivity and correlate MRI imaging features with pathology and local control. The trial is conducted at the Cancer Hospital, Chinese Academy of Medical Sciences in Beijing and enrolls adult patients judged suitable for preoperative radiotherapy and limb-conserving surgery.
Who should consider this trial
Good fit: Adults aged 18 or older with histology-confirmed primary truncal or extremity soft tissue sarcoma who are candidates for preoperative radiotherapy and limb-conserving surgery, have ECOG 0–3, and can tolerate anlotinib are appropriate.
Not a fit: Patients with excluded or benign histologies (for example DFSP or desmoid tumors), prior complete tumor resection, metastatic disease, or contraindications to anlotinib or severe organ dysfunction are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could shrink tumors before surgery, reduce local recurrence, and help preserve limb function.
How similar studies have performed: Combining anti-angiogenic TKIs with radiotherapy has shown activity in some sarcoma and other cancer settings, but preoperative IMRT plus anlotinib for extremity/trunk sarcoma is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ning-Ning Lu
- Email: Ning-Ning.Lu@hotmail.com
- Phone: +868611804268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.