- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., Lenvima (lenvatinib) / Eisai, Merck (MSD)
Biomarker, Journal, Tumor microenvironment, PD(L)-1 Biomarker, IO biomarker, Metastases: Identification of prognostic tumor microenvironment in patients with advanced hepatocellular carcinoma treated with hepatic arterial infusion chemotherapy combined with lenvatinib and PD-1 inhibitors. (Pubmed Central) - Dec 13, 2024 The differences in the initial TME of patients, especially in tumor-infiltrating T lymphocytes, may be potential biomarkers for predicting response and prognosis. This finding provides clues to search for biomarkers for this triple combination therapy in advanced HCC.
- |||||||||| erastin - Whitehead Institute for Biomedical Research, Dana / Farber Cancer Institute, Columbia University, Prolexys, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Study on the Synergistic Mechanism of Photodynamic Therapy Combined With Ferroptosis Inducer to Induce Ferroptosis in Cholangiocarcinoma. (Pubmed Central) - Dec 10, 2024 These findings highlight the connection between metabolic reprogramming and epigenetic regulation and suggest that targeting metabolic pathways may offer new strategies to overcome lenvatinib resistance in HCC. Our findings suggest that Erastin or Lenvatinib can enhance the induction of ferroptosis in cholangiocarcinoma cells by photodynamic therapy by increasing intracellular ROS and inhibiting intracellular antioxidant pathways.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Efficacy and Safety of Pembrolizumab in Combination With Lenvatinib in Metastatic Uveal MElanoma Patients (PLUME) (clinicaltrials.gov) - Dec 9, 2024 P2, N=51, Active, not recruiting, Our findings suggest that Erastin or Lenvatinib can enhance the induction of ferroptosis in cholangiocarcinoma cells by photodynamic therapy by increasing intracellular ROS and inhibiting intracellular antioxidant pathways. Recruiting --> Active, not recruiting | Trial completion date: Sep 2028 --> Nov 2026 | Trial primary completion date: Jan 2027 --> May 2025
- |||||||||| fostroxacitabine bralpamide (MIV-818) / Medivir
Trial completion date, Trial primary completion date: MIV-818-101: A Study to Evaluate MIV-818 in Patients with Liver Cancer Manifestations (clinicaltrials.gov) - Dec 6, 2024 P1/2, N=53, Active, not recruiting, The treatment with lenvatinib plus pembrolizumab or everolimus is less cost-effective than the sunitinib treatment for patients with advanced RCC in China and the United States. Trial completion date: Feb 2024 --> Jun 2025 | Trial primary completion date: Feb 2024 --> Dec 2024
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date: PRIMER-1: Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - Dec 6, 2024 P2, N=60, Recruiting, Trial completion date: Feb 2024 --> Jun 2025 | Trial primary completion date: Feb 2024 --> Dec 2024 Trial completion date: Jul 2026 --> Jul 2030 | Trial primary completion date: Jul 2026 --> Jul 2028
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment closed, Enrollment change, Trial primary completion date, Checkpoint inhibition, Metastases: Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Na (clinicaltrials.gov) - Dec 5, 2024 P2, N=6, Active, not recruiting, Trial completion date: Jul 2026 --> Jul 2030 | Trial primary completion date: Jul 2026 --> Jul 2028 Recruiting --> Active, not recruiting | N=30 --> 6 | Trial primary completion date: Jun 2025 --> Dec 2024
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Biomarker, Journal: Oncofetal MCB1 Is a Functional Biomarker for HCC Personalized Therapy. (Pubmed Central) - Dec 4, 2024 Furthermore, treatment of targeted drugs-resistant HCC with adeno-associated virus (AAV) targeting MCB1 or a proteasome inhibitor restores targeted drug response, suggesting their clinical significance in HCC combinational therapy. In conclusion, these findings demonstrate that MCB1 could act as a driver for HCC initiation, a contributor to drug resistance, and a biomarker for individualized HCC therapy.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Microchip Based Isolation and Drug Delivery of Patient-Derived Extracellular Vesicles Against Their Homologous Tumor. (Pubmed Central) - Dec 4, 2024 As is proven, PT-EVs exhibit robust tumor cell targeting and efficient receptor-mediated cellular uptake, and the efficacy of chemotherapeutic drugs is improved significantly. These results suggest that this platform could be a valuable tool for efficient isolation of PT-EVs and personalized drug customization, particularly when working with limited clinical samples, thus supporting personalized and precision medicine.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment change, Trial withdrawal: Lenvatinib, Pembrolizumab, and Tumor Treating Fields (TTFields) for Second-line Treatment of Glioblastoma (clinicaltrials.gov) - Dec 4, 2024 P1/2, N=0, Withdrawn, This study suggests that the efficacy of pembrolizumab-lenvatinib and atezolizumab-bevacizumab is comparable in first-line treatment of unresectable HCC, the atezolizumab-bevacizumab combination may confer additional benefits for patients with high CPA scores compared to pembrolizumab-lenvatinib. N=47 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal, Machine learning: Machine learning based ultrasomics noninvasive predicting EGFR expression status in hepatocellular carcinoma patients. (Pubmed Central) - Dec 3, 2024 The predictive performance of the combined model established by integrating ultrasomics features and clinical baseline characteristics was improved, with the AUC, sensitivity, specificity, and accuracy of the RF machine learning combined model for the training and test dataset reaching 0.937 (95%CI, 0.884-0.971), 0.822 (95%CI, 0.702-0.909); 0.857, 0.833; 0.857, 0.800; 0.857, 0.817, respectively. To predict the status of EGFR expression in HCC patients, the ultrasomics model and combined model created by five machine learning algorithms can be utilized as efficient and noninvasive techniques, and the ultrasomics model and combined model established by RF classifier have the best predictive performance.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion, Metastases: LEAP-003 China Extension: Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study (clinicaltrials.gov) - Dec 2, 2024 P3, N=131, Completed, The safety profile of the T+L+P regimen was acceptableThe incidence and severity of adverse reactions in the T+L+P group were not significantly different compared to the L+P group (any grade, 90.1 vs 93.6%, p=0.551; grade?3, 25.9 vs 23.8%, p=0.843). Active, not recruiting --> Completed
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Reserpine, a novel N6-methyladenosine regulator, reverses Lenvatinib resistance in hepatocellular carcinoma. (Pubmed Central) - Nov 30, 2024 Patients should feel confident that they can receive Kampo medicines as supportive care for lenvatinib therapy without a risk of drug interactions that could affect treatment efficacy. Reserpine, a small-molecule regulator of m6A, reverses Lenvatinib-resistant phenotypes, including proliferation, migration and anti-apoptosis, in vitro and in vivo by targeting SMAD3 and down-regulating the m6A level in HCC.
- |||||||||| Review, Journal: Systemic Therapy for Hepatocellular Carcinoma. (Pubmed Central) - Nov 29, 2024
Areas of development include testing immune checkpoint-based regimens in the adjuvant setting after surgery, ablation, or transarterial embolization. Also of interest are studies for patients with Child-Pugh B liver function and adding new checkpoint molecules to the current standard platforms.
- |||||||||| Enweida (envafolimab) / 3DMed, Ascletis
Trial completion date, Trial primary completion date, Metastases: Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer (clinicaltrials.gov) - Nov 28, 2024 P2, N=108, Recruiting, Also of interest are studies for patients with Child-Pugh B liver function and adding new checkpoint molecules to the current standard platforms. Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Aug 2024 --> Mar 2025
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Review, Journal: Renal microangiopathy induced by lenvatinib in hepatocellular carcinoma: a case report and literature review. (Pubmed Central) - Nov 28, 2024 The potential for lenvatinib to induce significant renal microvascular disease, as demonstrated in this case, emphasizes the importance of vigilant renal monitoring and personalized therapeutic strategies in patients treated with lenvatinib for HCC. Early intervention and dose adjustment may be crucial in preventing severe renal impairment, highlighting the significance of tailored treatment plans in the management of advanced HCC patients especially with pre-existing risk factors.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial) (clinicaltrials.gov) - Nov 26, 2024 P2, N=11, Active, not recruiting, Remote interventions, such as telephone follow-up, are useful means of managing adverse events in patients receiving oral anticancer drugs and can lead to improved treatment results. Trial completion date: Feb 2027 --> Dec 2025 | Trial primary completion date: Jul 2025 --> Jul 2024
- |||||||||| Folotyn (pralatrexate) / Aurobindo
Journal: Pralatrexate represses the resistance of HCC cells to molecular targeted agents via the miRNA-34a/Notch pathway. (Pubmed Central) - Nov 25, 2024 In HCC cells, knockdown of DHFR or treatment with pralatrexate enhanced the sensitivity of HCC cells to molecularly targeted agents, such as sorafenib, regorafenib, lenvatinib, cabozantinib, or anlotinib...Therefore, pralatrexate upregulates the sensitivity of HCC cells to molecularly targeted drugs. These results expand our understanding of folate metabolism and HCC and can help provide more options for HCC treatment.
- |||||||||| Tyvyt (sintilimab) / Eli Lilly, Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Clinical, Retrospective data, Journal, Metastases: Lenvatinib, sintilimab combined interventional treatment vs bevacizumab, sintilimab combined interventional treatment for intermediate-advanced unresectable hepatocellular carcinoma. (Pubmed Central) - Nov 22, 2024 These results expand our understanding of folate metabolism and HCC and can help provide more options for HCC treatment. In intermediate-to-advanced HCC, the BeSiIT and LeSiIT groups exhibited acceptable toxicities and comparable PFS, OS, and ORR.
- |||||||||| Cabometyx (cabozantinib tablet) / Exelixis
Journal: Real word outcomes of cabozantinib therapy in poorly differentiated thyroid carcinoma. (Pubmed Central) - Nov 20, 2024 Cabozantinib is an effective and reasonably well-tolerated treatment option for patients with PDTC. Prospective studies are needed to further investigate the role of cabozantinib in the treatment of PDTC, alone and in combination with other agents including checkpoint inhibitors.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Pneumatosis intestinalis and pneumoperitoneum secondary to treatment with lenvatinib. (Pubmed Central) - Nov 19, 2024 Pneumatosis intestinalis is a rare disorder that can be secondary to a variety of causes among which includes oncological treatment. Most cases due to oncological treatment are reported with targeted therapy but there is growing number of cases secondary to tyrosin kinase inhibitors that includes Lenvatinib which it can be used in the treatment of hepatocarcinoma.
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal, Combination therapy, Metastases: Hepatic arterial infusion chemotherapy in combination with lenvatinib and durvalumab versus standard first-line treatment gemcitabine and cisplatin plus durvalumab in advanced intrahepatic cholangiocarcinoma. (Pubmed Central) - Nov 18, 2024 Additionally, the rates of any grade and grade 3-4 adverse events were not significantly different between the two groups (100% vs. 92.9%, P = 0.221; 32.3% vs. 42.9%, P = 0.401; respectively). In conclusion, HLD treatment was tolerable and associated with better survival benefits compared to the standard first-line GCD treatment in patients with advanced ICC, especially in those with single tumor, intrahepatic tumors >5 cm, and unilobar tumors.
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