Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients With HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Summary

The purpose of this study is to evaluate the objective response rate (ORR) of Pembrolizumab combined with Lenvatinib and SOX compared with SOX alone in the treatment of patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.

Timeline

Start

2025-05-01

Primary completion

2027-04-30

Completion

2030-04-30

Publications

• Background Heinrich MC, Jones RL, von Mehren M, Schoffski P, Serrano C, Kang YK, Cassier PA, Mir O, Eskens F, Tap WD, Rutkowski P, Chawla SP, Trent J, Tugnait M, Evans EK, Lauz T, Zhou T, Roche M, Wolf BB, Bauer S, George S. Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open-label, phase 1 trial. Lancet Oncol. 2020 Jul;21(7):935-946. doi: 10.1016/S1470-2045(20)30269-2.
• Background Tang X, Yang J, Shi A, Xiong Y, Wen M, Luo Z, Tian H, Zheng K, Liu Y, Shu C, Ma N, Wang R, Zhao J. CD155 Cooperates with PD-1/PD-L1 to Promote Proliferation of Esophageal Squamous Cancer Cells via PI3K/Akt and MAPK Signaling Pathways. Cancers (Basel). 2022 Nov 15;14(22):5610. doi: 10.3390/cancers14225610.
• Background Lai X, Gupta SK, Schmitz U, Marquardt S, Knoll S, Spitschak A, Wolkenhauer O, Putzer BM, Vera J. MiR-205-5p and miR-342-3p cooperate in the repression of the E2F1 transcription factor in the context of anticancer chemotherapy resistance. Theranostics. 2018 Jan 1;8(4):1106-1120. doi: 10.7150/thno.19904. eCollection 2018.
• Background Furtado J. Decentralising HIV treatment in lower- and middle-income countries. Sao Paulo Med J. 2014 Dec;132(6):383. doi: 10.1590/1516-3180.20141326t2.
• Background Wang W, Kirsch T. Annexin V/beta5 integrin interactions regulate apoptosis of growth plate chondrocytes. J Biol Chem. 2006 Oct 13;281(41):30848-56. doi: 10.1074/jbc.M605937200. Epub 2006 Aug 16.
• Background Goser S, Ottl R, Brodner A, Dengler TJ, Torzewski J, Egashira K, Rose NR, Katus HA, Kaya Z. Critical role for monocyte chemoattractant protein-1 and macrophage inflammatory protein-1alpha in induction of experimental autoimmune myocarditis and effective anti-monocyte chemoattractant protein-1 gene therapy. Circulation. 2005 Nov 29;112(22):3400-7. doi: 10.1161/CIRCULATIONAHA.105.572396.
• Background Paulus BC, Adelman SL, Jamula LL, McCusker JK. Leveraging excited-state coherence for synthetic control of ultrafast dynamics. Nature. 2020 Jun;582(7811):214-218. doi: 10.1038/s41586-020-2353-2. Epub 2020 Jun 11.
• Background Hasson A, Jiang W, Benabdallah N, Lu P, Longtine MS, Beattie BJ, Summer L, Zhang H, Wahl RL, Abou DS, Thorek DLJ. Radiochemical Quality Control Methods for Radium-223 and Thorium-227 Radiotherapies. Cancer Biother Radiopharm. 2023 Feb;38(1):15-25. doi: 10.1089/cbr.2022.0023. Epub 2022 Sep 23.
• Background Walczak-Sztulpa J, Wawrocka A, Doornbos C, van Beek R, Sowinska-Seidler A, Jamsheer A, Bukowska-Olech E, Latos-Bielenska A, Grenda R, Bongers EMHF, Schmidts M, Obersztyn E, Krawczynski MR, Oud MM. Identical IFT140 Variants Cause Variable Skeletal Ciliopathy Phenotypes-Challenges for the Accurate Diagnosis. Front Genet. 2022 Jul 7;13:931822. doi: 10.3389/fgene.2022.931822. eCollection 2022.
• Background Zhu YZ, Zhong JX, Dong LL. Menstrual and Reproductive Characteristics of Patients with Primary Sjogren's Syndrome: A 7-year Single-center Retrospective Study. Curr Med Sci. 2023 Feb;43(1):139-145. doi: 10.1007/s11596-022-2675-4. Epub 2022 Dec 21.
• Background Monga J, Adrianto I, Rogers C, Gadgeel S, Chitale D, Alumkal JJ, Beltran H, Zoubeidi A, Ghosh J. Tribbles 2 pseudokinase confers enzalutamide resistance in prostate cancer by promoting lineage plasticity. J Biol Chem. 2022 Feb;298(2):101556. doi: 10.1016/j.jbc.2021.101556. Epub 2021 Dec 30.
• Background Bhowmick T, Liu C, Imp B, Sharma R, Boruchoff SE. Ceftaroline as salvage therapy for complicated MRSA bacteremia: case series and analysis. Infection. 2019 Aug;47(4):629-635. doi: 10.1007/s15010-019-01304-7. Epub 2019 Apr 6.
• Background Wang SM, Han C, Lee SJ, Jun TY, Patkar AA, Masand PS, Pae CU. Investigational dopamine antagonists for the treatment of schizophrenia. Expert Opin Investig Drugs. 2017 Jun;26(6):687-698. doi: 10.1080/13543784.2017.1323870. Epub 2017 May 12.
• Background Zhang MZ, Yao B, Wang S, Fan X, Wu G, Yang H, Yin H, Yang S, Harris RC. Intrarenal dopamine deficiency leads to hypertension and decreased longevity in mice. J Clin Invest. 2011 Jul;121(7):2845-54. doi: 10.1172/JCI57324. Epub 2011 Jun 23.
• Background Craig A, Kool J, Nilles E. The Pacific experience: supporting small island countries and territories to meet their 2012 International Health Regulations (2005) commitments. Western Pac Surveill Response J. 2013 Jul 3;4(3):14-8. doi: 10.5365/WPSAR.2012.3.4.007. eCollection 2013 Jul-Sep.
• Background Luo H, Li S, Zhao M, Sheng B, Zhu H, Zhu X. Prognostic value of progesterone receptor expression in ovarian cancer: a meta-analysis. Oncotarget. 2017 May 30;8(22):36845-36856. doi: 10.18632/oncotarget.15982.
• Background Ostergaard KH, Bertelsen MF, Brondum ET, Aalkjaer C, Hasenkam JM, Smerup M, Wang T, Nyengaard JR, Baandrup U. Pressure profile and morphology of the arteries along the giraffe limb. J Comp Physiol B. 2011 Jul;181(5):691-8. doi: 10.1007/s00360-010-0545-z. Epub 2011 Jan 5.
• Background Puza CJ, Warren WS, Mosca PJ. Correction to: The changing landscape of dermatology practice: melanoma and pump-probe laser microscopy. Lasers Med Sci. 2017 Dec;32(9):2173. doi: 10.1007/s10103-017-2339-y.
• Background Liu Y, Zhou K, Guo S, Wang Y, Ji X, Yuan Q, Su L, Guo X, Gu X, Xing J. NGS-based accurate and efficient detection of circulating cell-free mitochondrial DNA in cancer patients. Mol Ther Nucleic Acids. 2021 Jan 1;23:657-666. doi: 10.1016/j.omtn.2020.12.017. eCollection 2021 Mar 5.
• Background Almeida GJ, Khoja SS, Zelle BA. Effect of prehabilitation in older adults undergoing total joint replacement: An Overview of Systematic Reviews. Curr Geriatr Rep. 2020 Dec;9(4):280-287. doi: 10.1007/s13670-020-00342-6. Epub 2020 Nov 24.
• Background Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

Drugs

Indications