^
4d
A single-arm exploratory clinical study of penpulimab combined with anlotinib in the first-line treatment of advanced esophageal squamous cell carcinoma (ChiCTR2400089133)
P=N/A, N=30, Recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
New trial • Metastases
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Focus V (anlotinib) • albumin-bound paclitaxel • Anniko (penpulimab)
4d
Atezolizumab Plus Chemotherapy Followed by Atezolizumab Plus Anlotinib in First-line Therapy for Extensive-stage Small Cell Lung Cancer: A real-world study (ChiCTR2400088866)
P4, N=97, Recruiting, The First Affiliated Hospital of USTC (Anhui Provincial Hospital); The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
New P4 trial • Real-world evidence • Real-world
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Tecentriq (atezolizumab) • Focus V (anlotinib)
4d
New P3 trial • Metastases
|
Focus V (anlotinib)
4d
New P2 trial
|
cisplatin • gemcitabine • Focus V (anlotinib) • benmelstobart (APL-502)
4d
Prospective, open-label, phase II clinical study of the combination of Chidamide and Anlotinib ± PD-1/PD-L1 inhibitors in patients with SWI/SNF complex-deficient mutations (ChiCTR2400090522)
P2, N=57, Recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
New P2 trial • IO biomarker
|
ARID1A (AT-rich interaction domain 1A) • SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1) • SMARCA2 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily A, Member 2)
|
Focus V (anlotinib) • Epidaza (chidamide)
4d
A phase IIa clinical trial study on the efficacy and safety of bevacizumab combined with temozolomide concurrent radiotherapy followed by bevacizumab combined with temozolomide and anlotinib in the treatment of primary glioblastoma (ChiCTR2400091275)
P2, N=40, Not yet recruiting, Affiliated Cancer Hospital of Shandong First Medical University; Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandon
New P2 trial
|
IDH wild-type
|
Avastin (bevacizumab) • Focus V (anlotinib) • temozolomide
4d
An open, single-arm, exploratory clinical trial of anlotinib hydrochloride combined with chemoradiotherapy for the treatment of locally advanced cervical cancer (ChiCTR2400089617)
P2, N=30, Not yet recruiting, Gansu Provincial Maternal and Child Health Care Hospital/Gansu Provincial Central Hospital; Gansu Provincial Maternal and Child Health Care Hospital/G
New P2 trial • Metastases
|
CA 19-9 (Cancer antigen 19-9)
|
cisplatin • paclitaxel • Focus V (anlotinib)
4d
New P2 trial • Combination therapy • Metastases
|
Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi) • Epidaza (chidamide)
6d
New P2 trial • Metastases
|
Focus V (anlotinib) • Kaitanni (cadonilimab)
7d
Synergistic effects of anlotinib and DDP on breast cancer: targeting the VEGF/JAK2/STAT3 axis. (PubMed, Front Pharmacol)
However, its potential synergistic effects with DDP (cisplatin) in breast cancer (BRCA) remain to be fully elucidated. In vivo study further support these results, showing that anlotinib markedly inhibits tumor growth in xenografted mice. This study confirms the efficacy of anlotinib or in combination with DDP and elucidates the mechanism behind anlotinib's effectiveness, highlighting its role in inhibiting the JAK2/STAT3 pathway.
Journal • BRCA Biomarker
|
JAK2 (Janus kinase 2) • BRCA (Breast cancer early onset)
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VEGFA expression
|
cisplatin • Focus V (anlotinib)
16d
Combination therapy using low-dose anlotinib and immune checkpoint inhibitors for extensive-stage small cell lung cancer. (PubMed, Cancer Innov)
Grade 3/4 treatment-related AEs were observed in two patients (4.8%). A combination of low-dose anlotinib and immune checkpoint inhibitors as second-line or later treatment for ES-SCLC may achieve longer PFS and OS and have manageable AEs.
Journal • Combination therapy • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1)
|
Focus V (anlotinib)
16d
New P2/3 trial • Metastases
|
5-fluorouracil • Focus V (anlotinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Teysuno (gimeracil/oteracil/tegafur)
17d
Concurrent EGFR mutation and SMARCA4 deficiency in non-small cell lung cancer: A case report and literature review. (PubMed, Medicine (Baltimore))
This case underscores the transient efficacy of targeted therapy in SMARCA4-deficient NSCLC with concurrent EGFR mutations. It highlights the need for continuous therapeutic adjustments and emphasizes the importance of further research into effective strategies for treating this complex and challenging subset of NSCLC, as current modalities have limitations in sustained efficacy.
Review • Journal
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1) • LRP1B (LDL Receptor Related Protein 1B) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4)
|
TP53 mutation • KRAS mutation • EGFR mutation • EGFR L858R • STK11 mutation • KEAP1 mutation • SMARCA4 mutation • EGFR L858R + EGFR exon 21 deletion
|
Tagrisso (osimertinib) • Focus V (anlotinib)
17d
New P1 trial
|
Focus V (anlotinib) • Aidixi (disitamab vedotin)
17d
Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial). (PubMed, Signal Transduct Target Ther)
Significant tumor microenvironment changes were observed in pCR patients, including reduced VEGF+ cells and CD4+Foxp3+ Treg cells, and increased perivascular CD4+ T cells, CD39+CD8+ T cells, and M1 macrophages. In conclusion, perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy achieved pCR in a notable proportion of patients with resectable NSCLC and were associated with profound changes in the tumour microenvironment (ClinicalTrials.gov NCT05400070).
P2 data • Journal
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • FOXP3 (Forkhead Box P3) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
|
Focus V (anlotinib) • Tyvyt (sintilimab)
17d
New P2 trial • IO biomarker • Metastases
|
IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • IL17A (Interleukin 17A) • IFNA1 (Interferon Alpha 1) • IL1B (Interleukin 1, beta)
|
5-fluorouracil • Focus V (anlotinib) • benmelstobart (APL-502) • Onivyde (nanoliposomal irinotecan)
20d
Anlotinib plus TQB2450, a PD-L1 Antibody, in Patients with Advanced Alveolar Soft Part Sarcoma: a single-arm, phase 2 trial. (PubMed, Clin Cancer Res)
The combination of anlotinib and TQB2450 is effective and tolerable in ASPS patients. TLS may serve as a prognostic biomarker, meriting further investigation.
P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
|
Focus V (anlotinib) • benmelstobart (APL-502)
21d
A phase II study of anlotinib plus whole brain radiation therapy for patients with NSCLC with multiple brain metastases. (PubMed, Ann Med)
Dose adjustment due to AEs occurred in 17.9% of patients. Anlotinib combined with WBRT is effective and well-tolerated in patients with NSCLC with multiple BMs.
P2 data • Journal
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK mutation
|
Focus V (anlotinib)
24d
Analysis of clinical features, treatment methods, and prognostic influence factors in patients with malignant peripheral nerve sheath tumor (PubMed, Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi)
FNCLCC grade, R 0 resection, and adjuvant therapies, including radiotherapy and anlotinib-targeted therapy, are closely associated with MPNST prognosis. Complete surgical resection should be prioritized in clinical management, along with adjuvant treatments such as radiotherapy and targeted therapy of anlotinib to improve patient outcomes.
Retrospective data • Journal
|
NF1 (Neurofibromin 1)
|
Focus V (anlotinib)
27d
Case report: a case of lung squamous cell carcinoma with a novel FGFR3-IER5L fusion mutation responding to anlotinib. (PubMed, Front Oncol)
Anlotinib is a small molecular multi-target tyrosine kinase inhibitor, which can inhibit the activity of kinases including vascular endothelial growth factor receptor 2/3 (VEGFR2/3), fibroblast growth factor receptor 1-4 (FGFR1-4), platelet-derived growth factor receptor α/β (PDGFRα/β), and c-Kit. The patient achieved partial response and the progression-free survival was 3.8 months.
Journal
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KIT (KIT proto-oncogene, receptor tyrosine kinase) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • KDR (Kinase insert domain receptor)
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FGFR3 fusion
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Focus V (anlotinib)
30d
Nivolumab plus anlotinib hydrochloride in advanced gastric adenocarcinoma and esophageal squamous cell carcinoma: the phase II OASIS trial. (PubMed, Nat Commun)
For secondary objectives, disease control rate was 64.6%; median progression-free survival was 4.0 months; and median overall survival was 11.1 months with a manageable toxicity profile. The exploratory analyses unveiled that the balance of gut bacteria and the presence of a pre-existing immune signature characterized by a high percentage of CD68+PD-L1+ PD-1+ macrophages and low pretreatment variant allele frequencies (VAF), as well as low expression of certain cytokines were significantly associated with improved clinical outcomes in patients with GAC.
P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • CD68 (CD68 Molecule)
|
Opdivo (nivolumab) • Focus V (anlotinib)
1m
TQB2450-III-07: A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer (clinicaltrials.gov)
P3, N=528, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Jun 2025
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
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Focus V (anlotinib) • sunitinib • benmelstobart (APL-502)
1m
Case report: Fatal hemoptysis after effective treatment with tislelizumab and anlotinib in pulmonary sarcomatoid carcinoma. (PubMed, Front Oncol)
However, it also represents the first reported case of fatal hemoptysis with this specific treatment regimen. This finding emphasizes the need for increased awareness of this potential complication, especially in patients with centrally located PSC treated with anti-angiogenic agents like anlotinib.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
Focus V (anlotinib) • Tevimbra (tislelizumab-jsgr)
1m
Combination kinase inhibitors and immunotherapy for unresectable anaplastic thyroid carcinoma: A retrospective single-center study. (PubMed, Oral Oncol)
Combination kinase inhibitors with immunotherapy as first-line therapy are safe and effective for the treatment of unresectable ATC, especially with BRAF V600E mutation.
Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
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BRAF (B-raf proto-oncogene)
|
BRAF V600E
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Keytruda (pembrolizumab) • Mekinist (trametinib) • Tafinlar (dabrafenib) • Focus V (anlotinib) • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab)
1m
Anlotinib treatment for rapidly progressing pediatric embryonal rhabdomyosarcoma in the maxillary gingiva: a case report. (PubMed, Diagn Pathol)
Our study highlights the importance of accurate diagnosis established on multifaceted assessment for the effective treatment of ERMS. We present compelling evidence supporting the clinical use of anlotinib as a promising treatment strategy for pediatric ERMS patients, especially for those resistant to conventional chemotherapy.
Journal
|
HRAS (Harvey rat sarcoma viral oncogene homolog) • MDM2 (E3 ubiquitin protein ligase) • LRP1B (LDL Receptor Related Protein 1B) • GNAS (GNAS Complex Locus) • FOXO1 (Forkhead box O1) • MYOD1 (Myogenic Differentiation 1)
|
HRAS mutation • GNAS mutation
|
Focus V (anlotinib)
1m
Anlotinib reverses osimertinib resistance via inhibiting epithelial-to-mesenchymal transition and angiogenesis in non-small cell lung cancer. (PubMed, J Biomed Res)
The combined treatment of osimertinib and anlotinib effectively prevented the metastasis of resistant cells, which also inhibited tumor growth, exerted anti-tumor activity, and ultimately reversed osimertinib resistance in mice. The co-administration of osimertinib and anlotinib demonstrated their synergistic efficacy in inhibiting EMT and angiogenesis in three NSCLC patients, ultimately reversing osimertinib resistance.
Journal
|
CDH1 (Cadherin 1) • VIM (Vimentin)
|
Tagrisso (osimertinib) • Focus V (anlotinib)
1m
New P2 trial
|
gemcitabine • Focus V (anlotinib) • albumin-bound paclitaxel • benmelstobart (APL-502)
2ms
Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases (clinicaltrials.gov)
P2, N=40, Active, not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial
|
Focus V (anlotinib)
2ms
New P2 trial • Metastases
|
Focus V (anlotinib) • albumin-bound paclitaxel • oxaliplatin • Anniko (penpulimab) • lobaplatin (D19466)
2ms
A multi-cohort, open-label, exploratory study of radiotherapy combined with anlotinib hydrochloride capsules and tegafur suppositories for the treatment of elderly patients with oesophageal cancer (ChiCTR2400087078)
P4, N=240, Not yet recruiting, The Second Affiliated Hospital of Xi'an Jiaotong University; The Second Affiliated Hospital of Xi'an Jiaotong University
New P4 trial
|
Focus V (anlotinib)
2ms
New P2 trial
|
Focus V (anlotinib) • Anniko (penpulimab)
2ms
New P2 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Focus V (anlotinib) • Ariely (adebrelimab)
2ms
TQB2450-ALTN-II-02: Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=148, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Trial completion date: Mar 2026 --> Dec 2028 | Trial primary completion date: Sep 2025 --> Dec 2027
Trial completion date • Trial primary completion date • IO biomarker • Metastases
|
docetaxel • Focus V (anlotinib) • benmelstobart (APL-502)
2ms
P2 data • Journal • Metastases
|
FGFR1 (Fibroblast growth factor receptor 1) • FLT1 (Fms-related tyrosine kinase 1)
|
Focus V (anlotinib)
2ms
Sintilimab combined with anlotinib and chemotherapy as second-line or later therapy in extensive-stage small cell lung cancer: a phase II clinical trial. (PubMed, Signal Transduct Target Ther)
The trial design involved a combination therapy (sintilimab, anlotinib, and nab-paclitaxel) administered over six 21-day cycles, followed by maintenance sintilimab therapy. ctDNA analysis indicated that low on-treatment blood tumor mutation burden was associated with longer PFS and OS and a potential role of KMT2D mutation in treatment resistance. This combination therapy shows promising efficacy and a manageable safety profile as a second-line or later treatment for ES-SCLC, with genomic insights providing potential biomarkers for treatment response.
P2 data • Journal • Tumor mutational burden
|
TMB (Tumor Mutational Burden) • KMT2D (Lysine Methyltransferase 2D)
|
KMT2D mutation
|
Focus V (anlotinib) • Tyvyt (sintilimab) • albumin-bound paclitaxel
2ms
Increasing the tumour targeting of antitumour drugs through anlotinib-mediated modulation of the extracellular matrix and the RhoA/ROCK signalling pathway. (PubMed, J Pharm Anal)
Our bioinformatic analysis revealed a potential positive relationship between the ECM pathway and gefitinib resistance, poor treatment outcomes for programmed death 1 (PD-1) targeting, and unfavourable prognosis following chemotherapy in lung cancer patients. These findings suggest that, in addition to its antiangiogenic and vessel normalization effects, anlotinib can increase the distribution and retention of antitumour drugs in tumours by modulating ECM expression and physical properties through the RhoA/ROCK signalling pathway. These valuable insights contribute to the development of combination therapies aimed at improving tumour targeting in cancer treatment.
Journal • PD(L)-1 Biomarker • IO biomarker
|
RHOA (Ras homolog family member A)
|
gefitinib • Focus V (anlotinib)
2ms
New P2 trial • Combination therapy
|
Focus V (anlotinib) • Ivesa (firmonertinib)
2ms
Case report: outcome of anlotinib treatment in breast cancer patient with brain metastases. (PubMed, Front Pharmacol)
After the standard first-line treatment including albumin-bound paclitaxel, trastuzumab and pertuzumab, and a second-line treatment involving pyrotinib, capecitabine, and radiotherapy did not produce the desired results, the patient was then administered anlotinib in combination with pyrotinib and letrozole as a third-line treatment, which led to a partial response (PR). The findings suggest that anti-angiogenic therapy, specifically anlotinib, could be regarded as a promising therapeutic option for BC patients with BM.
Journal
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER negative • PGR positive • EGFR positive
|
Herceptin (trastuzumab) • Focus V (anlotinib) • Perjeta (pertuzumab) • capecitabine • Irene (pyrotinib) • albumin-bound paclitaxel • letrozole
2ms
Simultaneous determination of icotinib, osimertinib, aumolertinib, and anlotinib in human plasma for therapeutic drug monitoring by UPLC-MS/MS. (PubMed, J Pharm Biomed Anal)
Overall, the method proved to be sensitive, reliable, and straightforward, enabling successful simultaneous determination of blood concentrations of icotinib, osimertinib, aumolertinib, and anlotinib in patients. The validity of the method has been confirmed across various instruments.
Journal
|
FGFR (Fibroblast Growth Factor Receptor)
|
Tagrisso (osimertinib) • Focus V (anlotinib) • Conmana (icotinib) • Ameile (aumolertinib)
3ms
ALTER-BC-Ib-01: Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer (clinicaltrials.gov)
P1, N=42, Recruiting, Fudan University | Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jul 2024
Enrollment open • Trial initiation date
|
Focus V (anlotinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)
3ms
Anlotinib inhibits cervical cancer cell proliferation and invasion by suppressing cytokine secretion in activated cancer-associated fibroblasts. (PubMed, Front Oncol)
Anlotinib inhibits the pro-cancer effects of CAFs by suppressing the activation of CAFs and the secretion of pro-cancer cytokines. Our findings suggest that the combination of anlotinib and docetaxel may be a potential strategy for the treatment of refractory cervical cancer.
Journal
|
IL6 (Interleukin 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8)
|
docetaxel • Focus V (anlotinib)
3ms
Efficacy and Safety of Anlotinib in EGFR-Positive Patients with Advanced Lung Adenocarcinoma Compared with Chemotherapy: A Retrospective Study. (PubMed, Technol Cancer Res Treat)
Anlotinib is effective and safe in patients with EGFR-positive advanced LUAD. Patients without brain metastases had better clinical outcomes.
Retrospective data • Journal • Metastases
|
EGFR (Epidermal growth factor receptor)
|
Focus V (anlotinib)