Clinical trial · Interventional
Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma
A Prospective Multicenter Randomized Controlled Study of Preoperative Radiotherapy Combined With Targeted Therapy With or Without Immunotherapy for Soft Tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Soft tissue sarcoma is a rare cancer that often requires surgery combined with radiotherapy. Preoperative radiotherapy can improve the chance of complete tumor removal and limb preservation, but some patients still experience local recurrence, distant metastasis, or poor tumor response. This is a prospective, multicenter, randomized phase II study for patients with localized soft tissue sarcoma of the extremity or trunk who need preoperative radiotherapy. Participants will be randomly assigned to receive preoperative radiotherapy plus anlotinib, or preoperative radiotherapy plus anlotinib and penpulimab. Surgery will be performed after completion of neoadjuvant treatment according to the study protocol. The main purpose of this study is to evaluate whether adding penpulimab to preoperative radiotherapy and anlotinib can improve 3-year disease-free survival. The study will also assess pathological response, wound complications, treatment-related adverse events, local control, distant metastasis-free survival, overall survival, limb function, quality of life, and exploratory biomarkers related to treatment response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma (STS) | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Penpulimab | Drug | — | UNRESOLVED |
| Preoperative Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Preoperative Radiotherapy Plus Anlotinib
- description
- Preoperative Radiotherapy Plus Anlotinib
- interventionNames
- Drug: Anlotinib
- Radiation: Preoperative Radiotherapy
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- Arm B: Preoperative Radiotherapy Plus Anlotinib and Penpulimab
- description
- Preoperative Radiotherapy Plus Anlotinib and Penpulimab
- interventionNames
- Drug: Anlotinib
- Drug: Penpulimab
- Radiation: Preoperative Radiotherapy
- Procedure: Surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Primary or recurrent soft tissue sarcoma of the extremity or trunk with intermediate- to high-grade disease and tumor size \>=5 cm or deep-seated tumor, for which radiotherapy is recommended after multidisciplinary evaluation. * Age \>=15 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. * Histologically confirmed soft tissue sarcoma. * At least one evaluable lesion. * Able to tolerate radiotherapy, anlotinib, and penpulimab treatment. * Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use effective contraception during the treatment period and for 6 months after the last dose of study treatment. * Able to provide written informed consent. * Able and willing to comply with follow-up. Exclusion Criteria: * No gross tumor remaining after unplanned tumor resection performed at another hospital. * Contraindications to targeted therapy or immunotherapy due to comorbidities, including allergy, autoimmune disease, active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrolled hypertension, New York Heart Association class III-IV cardiac dysfunction, or severe hepatic or renal dysfunction. * Dermatofibrosarcoma protuberans, desmoid fibromatosis, tenosynovial giant cell tumor, or other locally aggressive diseases. * Benign tumors. * Sarcoma subtypes for which chemotherapy is recommended as the preferred neoadjuvant treatment according to guidelines, such as embryonal rhabdomyosarcoma or Ewing sarcoma. * Lipoma-like liposarcoma or well-differentiated liposarcoma. * New malignant tumor within 5 years before enrollment, except cervical carcinoma in situ, early-stage basal cell carcinoma of the skin, or early-stage lung cancer. * Soft tissue sarcoma that can be cured by wide local excision alone. * Prior radiotherapy to the same anatomical site. * Other severe medical comorbidities that would preclude surgery or participation in this study.
References
Publications (0)
Data not yet available