TACE Combined With Thermal Ablation and ADC, PD-1, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: A Multicenter, Single-arm Prospective Clinical Study.

Summary

This study is a multicenter, single-arm prospective clinical trial designed to evaluate the efficacy of TACE combined with thermal ablation, antibody-drug conjugates, immune checkpoint inhibitors, and first-line chemotherapy for the treatment of HER2 - highly expressing gastric cancer with liver metastases.

Timeline

Start

2026-08-01

Primary completion

2028-08-01

Completion

2029-08-01

Publications

• Results Xu J, Jiang H, Pan Y, Gu K, Cang S, Han L, Shu Y, Li J, Zhao J, Pan H, Luo S, Qin Y, Guo Q, Bai Y, Ling Y, Yang J, Yan Z, Yang L, Tang Y, He Y, Zhang L, Liang X, Niu Z, Zhang J, Mao Y, Guo Y, Peng B, Li Z, Liu Y, Wang Y, Zhou H; ORIENT-16 Investigators. Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2064-2074. doi: 10.1001/jama.2023.19918.
• Results Peng Z, Liu T, Wei J, Wang A, He Y, Yang L, Zhang X, Fan N, Luo S, Li Z, Gu K, Lu J, Xu J, Fan Q, Xu R, Zhang L, Li E, Sun Y, Yu G, Bai C, Liu Y, Zeng J, Ying J, Liang X, Xu N, Gao C, Shu Y, Ma D, Dai G, Li S, Deng T, Cui Y, Fang J, Ba Y, Shen L. Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study. Cancer Commun (Lond). 2021 Nov;41(11):1173-1182. doi: 10.1002/cac2.12214. Epub 2021 Oct 19.
• Results Wang X, Fan B, Liu S. Comprehensive treatment focusing on transarterial chemoembolization for postoperative liver metastasis in gastric cancer patients. Am J Transl Res. 2024 Dec 15;16(12):7330-7342. doi: 10.62347/KWBT3893. eCollection 2024.
• Results Vogl TJ, Gruber-Rouh T, Eichler K, Nour-Eldin NE, Trojan J, Zangos S, Naguib NN. Repetitive transarterial chemoembolization (TACE) of liver metastases from gastric cancer: local control and survival results. Eur J Radiol. 2013 Feb;82(2):258-63. doi: 10.1016/j.ejrad.2012.10.006. Epub 2012 Nov 3.

Drugs

Indications