Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma

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

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.