Evidence map›Paper›PMID 36753026›Full record

ArticleHepatology international2023

Real-world efficacy and prognostic factors of lenvatinib plus PD-1 inhibitors in 378 unresectable hepatocellular carcinoma patients.

Xu Yang, Bowen Chen, Yanyu Wang, Yunchao Wang, Junyu Long, Nan Zhang, Jingnan Xue, Ziyu Xun, Linzhi Zhang, Jiamin Cheng and 20 more

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Hepatology international, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 1 pooled it
11.0field-weighted citation impact, top 1% of its field
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.

NCT03892577 unknown statusnot on this map

Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.

Typeobservational_patient_registrySponsorPeking Union Medical College HospitalRan2017 to 2025Enrolled3,000ConditionsObjective Response Rate, Progression-free Survival, Overall Survival, Disease Control RateArmsPrecision oncology including targeted therapy and immunotherapy
NCT07412054 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Multicenter, Open-Label, Randomized, Phase II Study of Lenvatinib Plus Pembrolizumab With or Without Branched-Chain Amino Acids in Unresectable Hepatocellular Carcinoma

TypeinterventionalSponsorFudan UniversityRan2026 to 2028Enrolled234ConditionsHCC - Hepatocellular CarcinomaArmsLenvatinib, Pembrolizumab, Branched-Chain Amino Acids
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

  1. Pooled it
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  5. DamageZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2026
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  17. Blood pressure elevations post-lenvatinib treatment in hepatocellular carcinoma: a potential marker for better prognosis.Hypertension research : official journal of the Japanese Society of Hypertension · 2025
    Article
  18. Article
  19. Clinical predictive factors of the efficacy of immune checkpoint inhibitors and kinase inhibitors in advanced hepatocellular cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Article
  20. Review
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

30 authors at 7 institutions in 1 country.

Xu Yang *Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Bowen Chen *Peking University 302 Clinical Medical School, Beijing, China.
Yanyu Wang *Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Yunchao WangDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Junyu LongDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Nan ZhangDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Jingnan XueDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Ziyu XunDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Linzhi ZhangComprehensive Liver Cancer Center, The Fifth Medical Center of the PLA General Hospital, Beijing, 100039, China.
Jiamin ChengComprehensive Liver Cancer Center, The Fifth Medical Center of the PLA General Hospital, Beijing, 100039, China.
Jin LeiComprehensive Liver Cancer Center, The Fifth Medical Center of the PLA General Hospital, Beijing, 100039, China.
Huishan SunDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Yiran LiDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Jianzhen LinDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Fucun XieDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Dongxu WangDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Jie PanDepartment of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Ke HuCenter of Radiotherapy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Mei GuanDepartmentof Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Li HuoDepartment of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Jie ShiDepartment of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Lingxiang YuSenior Department of Oncology, The Fifth Medical Center of the PLA General Hospital, Beijing, China.
Lin ZhouSenior Department of Oncology, The Fifth Medical Center of the PLA General Hospital, Beijing, China.
Jinxue ZhouDepartment of Hepatobiliary and Pancreatic Surgery, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.
Zhenhui LuHepatobiliary and Pancreatic Surgery, Shenzhen Qianhai Shekou Free Trade Zone Hospital, Shenzhen, China.
Xiaobo YangDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Yilei MaoDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Xinting SangDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China.
Yinying LuPeking University 302 Clinical Medical School, Beijing, China. luyinying2017@sina.com.
Haitao ZhaoDepartment of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, 100730, China. zhaoht@pumch.cn.ORCID http://orcid.org/0000-0002-3444-8044
Chinese Academy of Medical Sciences & Peking Union Medical College · CNChinese PLA General Hospital · CNPeking University · CNGuangzhou Development Zone Hospital · CNGuiyang Medical University · CNTianjin Medical University Cancer Institute and Hospital · CNZhengzhou University · CN

Funding

CAMS Clinical and Translational Medicine Research Funds 2019XK320006Chinese Academy of Medical Sciences Initiative for Innovative Medicine 2021-1-I2M-003Chinese Academy of Medical Sciences Initiative for Innovative Medicine 2021-I2M-1-061CSCO-Hengrui Cancer Research Fund Y-HR2019-0239CSCO-Hengrui Cancer Research Fund Y-HR2020MS-0414CSCO-Hengrui Cancer Research Fund Y-HR2020QN-0415CSCO-MSD Cancer Research Fund Y-MSDZD2021-0213
6 · The paper itself

Abstract

introductionCombining lenvatinib with a programmed cell death protein-1 (PD-1) inhibitor has been explored for the treatment of un-resectable hepatocellular carcinoma (uHCC). This study aimed to investigate the real-world efficacy of and prognostic factors for survival associated with lenvatinib plus PD-1 inhibitor treatment in a large cohort of Asian uHCC patients even the global LEAP-002 study failed to achieve the primary endpoints.

methodsPatients with uHCC treated with lenvatinib and PD-1 inhibitors were included. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoints were the objective response rate (ORR) and adverse events (AEs). Prognostic factors for survival were also analyzed.

resultsA total of 378 uHCC patients from two medical centers in China were assessed retrospectively. The median patient age was 55 years, and 86.5% of patients were male. Hepatitis B virus (HBV) infection (89.9%) was the dominant etiology of uHCC. The median OS was 17.8 (95% confidence interval (CI) 14.0-21.6) months. The median PFS was 6.9 (95% CI 6.0-7.9) months. The best ORR and disease control rate (DCR) were 19.6% and 73.5%, respectively. In multivariate analysis, Child‒Pugh grade, Barcelona Clinic Liver Cancer stage, Eastern Cooperative Oncology Group performance status score, involved organs, tumor burden score, and combination with local therapy were independent prognostic factors for OS. A total of 100% and 57.9% of patients experienced all-grade and grade 3/4 treatment-emergent AEs, respectively.

conclusionThis real-world study of lenvatinib plus PD-1 inhibitor treatment demonstrated long survival and considerable ORRs and DCRs in uHCC patients in China. The tolerability of combination therapy was acceptable but must be monitored closely.

Indexed as

Carcinoma, HepatocellularHepatitis BLiver NeoplasmsFemaleHepatitis B virusHumansImmune Checkpoint InhibitorsMaleMiddle AgedPhenylurea CompoundsPrognosisQuinolinesRetrospective StudiesImmune Checkpoint InhibitorslenvatinibPhenylurea CompoundsQuinolinesAdverse eventsHepatitis B virusHepatocellular carcinomaLenvatinibNivolumabPD-1 inhibitorPembrolizumabUn-resectable

Identifiers

PMID36753026
PMCPMC9907200
OpenAlexW4319459456

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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.