Jiangmen Central Hospital

Chemotherapy combined with PD-1 inhibitor immunotherapy is the standard treatment for advanced esophageal squamous cell carcinoma (ESCC), yet patient prognosis remains unsatisfactory, with a median PFS of only about 6 months and a 1-year PFS rate of only 25%. Adding anlotinib maintenance therapy on top of PD-1 inhibitor immunotherapy maintenance after chemoimmunotherapy may improve progression-free survival and overall survival. We plan to conduct a randomized, multicenter, open-label Phase II study of anlotinib combined with PD-1 inhibitor maintenance therapy versus PD-1 inhibitor monotherapy maintenance in advanced ESCC. A total of 112 patients with unresectable locally advanced, recurrent, or metastatic ESCC are planned to be enrolled. After enrollment, patients will receive either anlotinib combined with PD-1 inhibitor maintenance therapy or PD-1 inhibitor monotherapy maintenance, with a maximum treatment duration of 2 years. This study aims to evaluate the efficacy and safety of anlotinib combined with PD-1 inhibitor maintenance therapy in advanced ESCC by comparing it with the PD-1 inhibitor monotherapy maintenance group, further optimizing the comprehensive treatment model for esophageal cancer.

Malignant tumors of the biliary system are highly invasive and malignant with an increasing incidence rate. Comprehensive drug therapy is the main treatment for advanced biliary tract tumors, yet the current gemcitabine plus platinum-based chemotherapy regimens yield suboptimal efficacy maintenance in patients with advanced biliary tract tumors. There is an urgent need for effective second-line treatment regimens for advanced biliary tract tumors. Vicinecumab is a recombinant humanized anti-EGFR monoclonal antibody generated by conjugating a potent cytotoxic small molecule to trastuzumab. It inhibits tumor cell proliferation and promotes tumor cell death by blocking various cellular physiological functions including mitosis. Current research data have demonstrated that in patients with recurrent and metastatic nasopharyngeal carcinoma who have received systemic therapy, vicinecumab can significantly improve patients' survival and prognosis compared with the chemotherapy group, with a manageable safety profile. Therefore, this study aims to observe and evaluate the efficacy and safety of vicinecumab in the second-line and subsequent treatment of advanced biliary tract tumors.

Venetoclax (Ven) resistance is common in the treatment of acute myeloid leukemia (AML). Patients with Ven resistance have poor response and survival, except those with specific targeted therapy. Whether we could use new BCL-2 inhibitors to replace Ven and combine with the agents which have been shown to enhance the antilekeumia effect of BCL-2 inhibitors, to overcome Ven resistance? This is unknown up until now. This multi-center, prospective, open-label, single-arm study will evaluate the efficacy and safety of homoharringtonine combined with lisaftoclax and azacitidine (HLA) as salvage therapy for adults with AML after failure of a Ven-containing regimen. Ven treatment failure is defined as no response after at least two consecutive cycles of a Ven-containing regimen or relapse during continued, protocol-compliant Ven-based therapy after a prior response. The study plans to enroll 73 participants. The primary endpoint is the overall response rate after two treatment cycles. Secondary endpoints include complete remission (CR), CR with incomplete blood count recovery (CRi), measurable residual disease (MRD) negativity, survival and relapse, and treatment-related adverse events.