Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Provincial People's Hospital

About this trial

Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma

Eligibility criteria

Qualifiers

Age 18-75 years.

ECOG Performance Status score of 0-1.

Histologically or cytologically confirmed diagnosis of high-grade soft tissue sarcoma (G2-G3), classified as moderately sensitive or higher to chemotherapy (or determined suitable for radiotherapy and chemotherapy by the investigator). Typically includes histological types such as synovial sarcoma, vascular sarcoma, adult fibrosarcoma, intramuscular chondrosarcoma, leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, hepatic undifferentiated embryonic sarcoma, and unclassified soft tissue sarcomas.

Clinical confirmation of soft tissue sarcoma suitable for surgical resection after multidisciplinary assessment.

Disqualifiers

Active autoimmune disease or history of autoimmune disease.

Receipt of any form of anti-tumor treatment within 4 weeks prior to enrollment, including radiotherapy, chemotherapy, molecular targeted therapy (such as angiogenesis inhibitors like sunitinib, sorafenib, imatinib, famitinib, regorafenib), and immunotherapy (eligible if last anti-tumor drug was stopped ≥5 half-lives before enrollment), or participation in another interventional clinical trial.

History of or current simultaneous malignancy within 3 years, excluding cured lung cancer, cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)].

Unresectable sarcomas, including severe vascular, neural, or bone involvement, or cases where complete surgical resection is not safely feasible.

Trial design

Treatments tested in this trial

  • Anlotinib

Treatment groups

39 Participants
are divided into 1 treatment group