Sintilimab plus Anlotinib in Patients with Pretreated Locally Advanced or Metastatic Sarcoma: A Prospective, Single-Arm, Phase II Clinical Trial.

ABSTRACT: Advanced sarcomas have limited treatment options after standard therapy, and therefore we investigated the efficacy and safety of sintilimab plus anlotinib in this setting. Patients age 18 to 75 years with advanced sarcomas and prior systemic therapy were enrolled. Patients with untreated, primary chemotherapy-resistant tumor types, such as alveolar soft-part sarcoma and clear-cell sarcoma, were also included. Patients received sintilimab 200 mg (day 1) and anlotinib (8, 10, or 12 mg investigator-chosen, day 1-14) every 3 weeks. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and adverse events (AE). The predictive value of tertiary lymphoid structure (TLS) was explored.

SUBMITTER: Fu H 

PROVIDER: S-EPMC12580780 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature