Focus V (anlotinib)

P2, N=40, Recruiting, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

P2, N=27, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Trial completion date: Jan 2025 --> Apr 2027 | Trial primary completion date: Aug 2024 --> Apr 2026

This regimen was associated with improved DCR, PFS, and OS compared to bevacizumab plus chemotherapy in patients with HER2-negative MBC. These findings suggest that anlotinib may represent a promising therapeutic option for patients for whom ADC drugs are inaccessible or unsuitable; however, further prospective, randomized studies are warranted to confirm.

P1, N=20, Terminated, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=43 --> 20 | Trial completion date: Feb 2026 --> Jun 2025 | Recruiting --> Terminated | Trial primary completion date: Oct 2025 --> Jun 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

In vivo, significant downregulation of p-PI3K, p-Akt, Bcl-2, and HIF1-α, and upregulation of BAX protein expression confirmed that the mechanism of action of combination therapy is related to PI3K/Akt pathway. The combination of PAM and ANL was more effective than monotherapy for treating ovarian cancer and holds potential to become a new therapeutic approach for ovarian cancer.

P2, N=30, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Trial completion date: Dec 2023 --> Dec 2027 | Trial primary completion date: Apr 2023 --> Dec 2027

Second-line treatment with tislelizumab, nab-paclitaxel, carboplatin, and anlotinib led to temporary stabilization. Salvage chemotherapy with doxorubicin, ifosfamide, and dacarbazine failed, and the patient died two months later...Patients who undergo complete resection of metastatic lesions tend to achieve better outcomes, whereas responses to systemic therapy are generally poor. Early identification of high-risk features and consideration of retroperitoneal lymph node dissection may improve prognosis in selected patients.

P2, N=30, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025

Our findings directly inform clinical guidelines, address gaps in current therapeutic decision-making. Durvalumab or pembrolizumab combined with GC are optimal first-line regimens for advanced BTC, balancing survival benefits and safety. Sintilimab plus anlotinib combined with GC demonstrates superior PFS but requires further validation. While EGFR inhibitors plus chemotherapy demonstrate potential in KRAS wild-type patients, confirmation in large-scale RCTs is required. PD-L1 expression may represent a promising predictive biomarker for response to PD-1 inhibitor therapy.

Aumolertinib plus anlotinib was effective and well-tolerated as first-line therapy in EGFR-mutant NSCLC patients with BMs. Trial Registration: ClinicalTrials.gov(identifier NCT04978753, registered July 20, 2021).

P2, N=20, Recruiting, The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting --> Recruiting

Radiopharmaceuticals such as 131I-MIBG and 177Lu-DOTATATE continue to play a pivotal role, achieving disease control in many patients. Cytotoxic regimens, particularly temozolomide, remain relevant, with some studies suggesting that SDHB-mutated PPGLs demonstrate a heightened sensitivity associated with MGMT promoter hypermethylation and reduced MGMT expression. Targeted agents are increasingly important: multi-kinase inhibitors such as sunitinib, anlotinib, and cabozantinib have shown meaningful activity. The landmark approval of belzutifan, a HIF-2α inhibitor, in 2025 represents the first oral targeted therapy for advanced/metastatic PPGL, which is particularly relevant for pseudohypoxic Cluster 1 tumors...This review summarizes current evidence and highlights ongoing clinical trials, underscoring a paradigm shift toward precision medicine and rational combination strategies. Collectively, these advances bring cautious optimism that metastatic PPGLs may soon become a more manageable chronic disease with improved survival and quality of life.