Evidence map›Paper›PMID 34665942›Full record

Trial reportCancer communications (London, England)2021

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.

Zhi Peng, Tianshu Liu, Jia Wei, Airong Wang, Yifu He, Liuzhong Yang, Xizhi Zhang, Nanfeng Fan, Suxia Luo, Zhen Li and 25 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer communications (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07602140 (TACE Combined With Thermal Ablation and Antibody-drug Conjugates, Immune Checkpoint Inhibitors, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases), which is not on this map. Cited by 139 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
139citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07602140 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

TACE Combined With Thermal Ablation and Antibody-drug Conjugates, Immune Checkpoint Inhibitors, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: a Multicenter, Single-arm Prospective Clinical Study.

TypeinterventionalSponsorShandong Provincial HospitalRan2026 to 2029Enrolled40ConditionsGastric Cancer With Liver MetastasesArmsTACE combined with thermal ablation, Targeted Therapy, Immunotherapy, Chemotherapy
3 · Its place in the literature

Who cites it

139 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  15. Antibody-Drug Conjugates in the Treatment of Esophageal Cancer.Current treatment options in oncology · 2026
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  20. [Conversion therapy for hepatoid adenocarcinoma of the stomach: A case report].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2026
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79 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors.

Zhi PengDepartment of Gastrointestinal Oncology, Key Laboratory of Cancinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, P. R. China.
Tianshu LiuDepartment of Gastrointestinal Oncology, Affiliated Zhongshan Hospital of Fudan University, Shanghai, 200032, P. R. China.
Jia WeiDepartment of Oncology, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210008, P. R. China.
Airong WangDepartment of Oncology, Weihai Municipal Hospital, Weihai, Shandong, 264299, P. R. China.
Yifu HeDepartment of Oncology, Anhui Provincial Cancer Hospital, Hefei, Anhui, 230031, P. R. China.
Liuzhong YangDepartment of Oncology, The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan, 453100, P. R. China.
Xizhi ZhangDepartment of Oncology, Subei People's Hospital, Yangzhou, Jiangsu, 225009, P. R. China.
Nanfeng FanDepartment of Abdominal Oncology, Fujian Provincial Cancer Hospital, Fuzhou, Fujian, 350014, P. R. China.
Suxia LuoDepartment of Gastrointestinal Oncology, Henan Cancer Hospital, Zhengzhou, Henan, 450003, P. R. China.
Zhen LiDepartment of Oncology, Linyi Cancer Hospital, Linyi, Shandong, 276002, P. R. China.
Kangsheng GuDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, P. R. China.
Jianwei LuDepartment of Oncology, Jiangsu Cancer Hospital, Nanjing, Jiangsu, 210009, P. R. China.
Jianming XuDepartment of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, 100039, P. R. China.
Qingxia FanDepartment of Oncology, The First Affiliated Hospital of Zhengzhou, Zhengzhou, Henan, 450099, P. R. China.
Ruihua XuDepartment of Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China.
Liangming ZhangDepartment of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, 264099, P. R. China.
Enxiao LiDepartment of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710061, P. R. China.
Yuping SunDepartment of Oncology, Jinan Central Hospital, Jinan, Shandong, 250013, P. R. China.
Guohua YuDepartment of Oncology, Weifang People's Hospital, Weifang, Shandong, 261041, P. R. China.
Chunmei BaiDepartment of Oncology, Peking Union Medical College Hospital, Beijing, 100005, P. R. China.
Yong LiuDepartment of Oncology, Xuzhou Central Hospital, Xuzhou, Jiangsu, 221009, P. R. China.
Jiangzheng ZengDepartment of Oncology, The First Affiliated Hospital of Hainan Hospital, Haikou, Hainan, 570102, P. R. China.
Jieer YingDepartment of Abdominal Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310005, P. R. China.
Xinjun LiangDepartment of Oncology, Hubei Cancer Hospital, Wuhan, Hubei, 430079, P. R. China.
Nong XuDepartment of Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310003, P. R. China.
Chao GaoDepartment of Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221004, P. R. China.
Yongqian ShuDepartment of Oncology, Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, P. R. China.ORCID 0000-0003-0802-1677
Dong MaDepartment of Oncology, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, P. R. China.
Guanghai DaiDepartment of Oncology, Chinese PLA General Hospital, Beijing, 100036, P. R. China.
Shengmian LiDepartment of Gastrointestinal Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050011, P. R. China.
Ting DengDepartment of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300181, P. R. China.
Yuehong CuiDepartment of Gastrointestinal Oncology, Affiliated Zhongshan Hospital of Fudan University, Shanghai, 200032, P. R. China.
Jianmin FangRemeGen, Ltd., Beijing, 100020, P. R. China.
Yi BaDepartment of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300181, P. R. China.ORCID 0000-0003-0255-4376
Lin ShenDepartment of Gastrointestinal Oncology, Key Laboratory of Cancinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, 100142, P. R. China.

Funding

Beijing Municipal Health Commission 2020-1-1022Ministry of Science and Technology of China 2017YFC1308900Ministry of Science and Technology of China 2018ZX09201-015National Natural Science Foundation of China 91959205RemeGen Co., LtdThe third batch of public welfare development and reform pilot projects of Beijing Municipal Medical Research Institutes: Beijing Medical Research 2019-1
6 · The paper itself

Abstract

backgroundCurrent treatment options for human epidermal growth factor receptor 2 (HER2)-overexpressing gastric cancer at third-line have shown limited clinical benefit. Further, there is no specific treatment for HER2 immunohistochemistry (IHC) 2+ and fluorescence in-situ hybridization-negative patients. Here, we report the efficacy and safety of a novel anti-HER2 antibody RC48 for patients with HER2-overexpressing, advanced gastric or gastroesophageal junction cancer.

methodsPatients with HER2-overexpressing (IHC 2+ or 3+), locally advanced or metastatic gastric or gastroesophageal junction cancer who were under at least second-line therapy were eligible and received RC48 2.5 mg/kg alone every 2 weeks. The primary endpoint was the objective response rate (ORR) assessed by an independent review committee. Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, time to progression, disease control rate, and safety.

resultsOf 179 patients screened, 125 were eligible and received RC48 treatment. The ORR was 24.8% (95% confidence interval [CI]: 17.5%-33.3%). The median PFS and OS were 4.1 months (95% CI: 3.7-4.9 months) and 7.9 months (95% CI: 6.7-9.9 months), respectively. The most frequently reported adverse events were decreased white blood cell count (53.6%), asthenia (53.6%), hair loss (53.6%), decreased neutrophil count (52.0%), anemia (49.6%), and increased aspartate aminotransferase level (43.2%). Serious adverse events (SAEs) occurred in 45 (36.0%) patients, and RC48-related SAEs were mainly decreased neutrophil count (3.2%). Seven patients had adverse events that led to death were not RC48-related.

conclusionsRC48 showed promising activity with manageable safety, suggesting potential application in patients with HER2-overexpressing, advanced gastric or gastroesophageal junction cancer who have previously received at least two lines of chemotherapy.

Indexed as

Stomach NeoplasmsAntibodies, Monoclonal, HumanizedErb-b2 Receptor Tyrosine KinasesEsophagogastric JunctionHumansAntibodies, Monoclonal, HumanizedERBB2 protein, humanErb-b2 Receptor Tyrosine Kinasesantibody-drug conjugategastric cancerHER2-overexpressingphase II clinical trialRC48third-line therapy

Identifiers

PMID34665942
PMCPMC8626607

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.