Neoadjuvant therapy for soft tissue sarcoma in the limbs

The Total Neoadjuvant Therapy for Hypofractionated Radiotherapy Combined with AI Regimens in Soft Tissue Sarcoma of the Extremities: a Phase 2 Single Arm Multicenter Study

This study is testing a new treatment for patients with localized soft tissue sarcomas in the arms or legs to see if a shorter course of radiation combined with immunotherapy can help control the cancer better and lower the chances of it coming back.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06593899 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a new treatment approach for localized soft tissue sarcomas (STS) of the extremities, combining hypofractionated radiotherapy with three cycles of adjuvant immunotherapy. The study aims to reduce the duration of radiotherapy while improving local control and minimizing the risk of distant metastasis. Participants will receive a 1-week hypofractionated radiotherapy regimen followed by immunotherapy to target potential micrometastases. The trial is designed for patients who are at high risk of recurrence after surgery and conventional treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with high-grade or large soft tissue sarcomas of the extremities who can tolerate the proposed treatment.

Not a fit: Patients with gross tumors after unplanned resection or those with significant comorbidities that preclude the use of immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce treatment duration and improve survival rates for patients with soft tissue sarcomas.

How similar studies have performed: Previous studies have shown promising results with hypofractionated radiotherapy regimens, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Primary soft tissue sarcoma of the extremities, with one of the following characteristics: high grade, ≥5cm or deep tumor, the need for neoadjuvant radiotherapy was determined after multidisciplinary consultation.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
3. Age 18-75 years old.
4. Histologic diagnosis of soft tissue sarcoma.
5. Can tolerate radiotherapy and AI regimen treatment.
6. The function of major organs is normal.

Exclusion Criteria:

1. There were no patients with gross tumors after unplanned mass resection in another hospital.
2. Patients with other comorbidities cannot use AI chemotherapy: drug allergy, active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency (NYHA standards), severe liver and renal insufficiency ( Level IV) etc.
3. New malignant tumors within 5 years (except cervical carcinoma in situ or early cutaneous basal cell carcinoma).
4. Pathological types: nonpleomorphic rhabdomyosarcoma, Ewing sarcoma.
5. Soft tissue sarcoma curable by simple expansion.
6. Previous history of radiotherapy to the same site.
7. Combined with distant metastasis (M1) or lymph node metastasis (N1).
8. Have other severe medical comorbidities that preclude surgery or participation in the study.
9. Previous exposure to chemotherapy.

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Principal investigator: Yong Yang, Doctor — Director of the radiotherapy department
• Study coordinator: Yong Yang, Doctor

Conditions: Soft Tissue Sarcomas