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    DRUG:

    Focus V (anlotinib)

    i
    Other names: AL3818, AL-3818, ALTN, AL 3818
    Company:
    Advenchen, Sino Biopharm
    Drug class:
    Multi-tyrosine kinase inhibitor
    Related drugs:
    3d
    Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Focus V (anlotinib) • temozolomide • vincristine
    3d
    A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=578, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University
    New P3 trial
    |
    TP53 (Tumor protein P53) • FAT1 (FAT atypical cadherin 1) • NOTCH3 (Notch Receptor 3)
    |
    TP53 mutation
    |
    cisplatin • paclitaxel • Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi) • Andewei (benmelstobart)
    4d
    Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients. (clinicaltrials.gov)
    P3, N=134, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P3 trial
    |
    Focus V (anlotinib)
    7d
    Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers (clinicaltrials.gov)
    P1, N=16, Not yet recruiting, Advenchen Laboratories Nanjing Ltd.
    New P1 trial
    |
    Focus V (anlotinib) • itraconazole
    7d
    Anlotinib and Benmelstobart in DTC (clinicaltrials.gov)
    P2, N=23, Not yet recruiting, Fudan University | Initiation date: Oct 2025 --> Apr 2026
    Trial initiation date
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    9d
    Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS) (clinicaltrials.gov)
    P3, N=325, Recruiting, Advenchen Laboratories, LLC | Active, not recruiting --> Recruiting | Trial completion date: Jun 2025 --> Dec 2028 | Trial primary completion date: Dec 2024 --> Dec 2027
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Focus V (anlotinib) • dacarbazine • midazolam hydrochloride
    11d
    Circulating tumor DNA as a prognostic biomarker in metastatic colorectal cancer: Post-hoc analysis of treatment response and survival outcomes in the ALTER-C-002 study. (PubMed, Biomol Biomed)
    This study evaluated the association between baseline ctDNA levels and changes in ctDNA during treatment with response and survival outcomes in the phase II ALTER-C-002 trial, which investigated first-line anlotinib combined with capecitabine and oxaliplatin in patients with rat sarcoma (RAS) and B-Raf proto-oncogene (BRAF) wild-type metastatic colorectal cancer. Furthermore, KRAS/BRAF mutations detected in ctDNA were linked to shorter PFS and OS (all p<0.05). In conclusion, baseline ctDNA burden and early ctDNA clearance may function as prognostic and on-treatment biomarkers of therapeutic efficacy in metastatic colorectal cancer, warranting prospective validation.
    Retrospective data • Journal • Circulating tumor DNA
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)
    |
    KRAS mutation • BRAF mutation • BRAF wild-type
    |
    Focus V (anlotinib) • capecitabine • oxaliplatin
    12d
    Long-term durable response to Sintilimab therapy in synchronous lung squamous cell carcinoma and gastric adenocarcinoma: a rare case report. (PubMed, Front Oncol)
    He was treated with Sintilimab plus Anlotinib, resulting in lung lesion regression. Both tumors showed high proliferative indices (Ki-67 ~80-90%) and PD-L1 expression, supporting responsiveness to immune checkpoint blockade. This case highlights the feasibility of immune monotherapy in managing complex synchronous malignancies, especially when standard treatments are declined.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Focus V (anlotinib) • Tyvyt (sintilimab)
    15d
    NeoLATC: Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer (clinicaltrials.gov)
    P=N/A, N=120, Recruiting, Fujian Medical University
    New trial
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Mekinist (trametinib) • Tafinlar (dabrafenib) • Focus V (anlotinib) • Lenvima (lenvatinib) • Retevmo (selpercatinib) • Gavreto (pralsetinib)
    17d
    Phase II trial of anlotinib-chemotherapy combination in pretreated HER2-negative metastatic breast cancer: therapeutic efficacy and proteomic biomarker profiling. (PubMed, NPJ Breast Cancer)
    No treatment-related fatalities were observed. This trial is registered with www.chictr.org.cn (ChiCTR2400081835) on 13 March 2024.
    P2 data • Journal • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • CSF1 (Colony stimulating factor 1)
    |
    HER-2 negative
    |
    Focus V (anlotinib)
    17d
    Anlotinib Capsules in the Treatment for IPF/PF-ILDs (clinicaltrials.gov)
    P2/3, N=30, Recruiting, First Affiliated Hospital of Wenzhou Medical University | Trial completion date: Dec 2026 --> Sep 2026 | Trial primary completion date: Dec 2026 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    Focus V (anlotinib)
    19d
    Anlotinib ameliorates myositis-associated interstitial lung disease (MAILD) via suppression of the NETs-PI3K/Akt-driven epithelial-mesenchymal transition. (PubMed, RMD Open)
    Anlotinib alleviates MAILD progression by inhibiting the NETs-PI3K/Akt axis and subsequent EMT, providing a theoretical basis for drug repurposing and supporting its clinical translation potential in MAILD.
    Journal
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CDH1 (Cadherin 1) • IL1B (Interleukin 1, beta) • MPO (Myeloperoxidase)
    |
    Focus V (anlotinib)