Evidence map›Paper›PMID 36455168›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Pembrolizumab Versus Placebo as Second-Line Therapy in Patients From Asia With Advanced Hepatocellular Carcinoma: A Randomized, Double-Blind, Phase III Trial.

Shukui Qin, Zhendong Chen, Weijia Fang, Zhenggang Ren, Ruocai Xu, Baek-Yeol Ryoo, Zhiqiang Meng, Yuxian Bai, Xiaoming Chen, Xiufeng Liu and 10 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03062358 (A Phase III Randomized Double-blind Study of Pembrolizumab Plus Best Supportive Care vs. Placebo Plus Best Supportive Care as Second-Line Therapy in Asian Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 141 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
141citing papers in PubMed, 13 pooled it
23.5field-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.

NCT03062358 phase3completednot on this map

A Phase III Randomized Double-blind Study of Pembrolizumab Plus Best Supportive Care vs. Placebo Plus Best Supportive Care as Second-Line Therapy in Asian Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-394)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2024Enrolled453ConditionsCarcinoma, HepatocellularArmspembrolizumab, placebo, best supportive care (BSC)
3 · Its place in the literature

Who cites it

141 citing papers in PubMed, 13 syntheses or guidelines pooled it, 176 citations in OpenAlex.

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81 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 4 countries.

Shukui QinJinling Hospital, Nanjing University of Chinese Medicine, Nanjing, China.ORCID 0000-0003-2289-1521
Zhendong ChenThe Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Weijia FangThe First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China.ORCID 0000-0001-9849-347X
Zhenggang RenZhongshan Hospital, Fudan University, Shanghai, China.
Ruocai XuHunan Cancer Hospital, Changsha, China.
Baek-Yeol RyooAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-9052-833X
Zhiqiang MengFudan University Shanghai Cancer Center, Shanghai, China.
Yuxian BaiHarbin Medical University Cancer Hospital, Harbin, China.
Xiaoming ChenGuangdong Provincial People's Hospital, Guangzhou, China.
Xiufeng LiuJinling Hospital, Nanjing University of Chinese Medicine, Nanjing, China.
Juxiang XiaoThe First Affiliated Hospital of Xi'An Jiaotong University, Xi'an, China.
Gwo Fuang HoUniversity Malaya Medical Centre, Kuala Lumpur, Malaysia.ORCID 0000-0002-2620-9174
Yimin MaoShanghai Jiaotong University School of Medicine, Renji Hospital, Shanghai, China.
Xin WangWest China Hospital of Sichuan University, Chengdu, China.
Jieer YingCancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.
Jianfeng LiMSD China, Beijing, China.
Wenyan ZhongMSD China, Shanghai, China.
Yu ZhouMSD China, Shanghai, China.
Abby B SiegelMerck & Co, Inc, Rahway, NJ.
Chunyi HaoPeking University Cancer Hospital, Beijing, China.
Nanjing University of Chinese Medicine · CNAnhui Medical University · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNFirst Affiliated Hospital Zhejiang University · CNFudan University Shanghai Cancer Center · CNGuangdong Academy of Medical Sciences · CNHarbin Medical University · CNHunan Cancer Hospital · CNMerck & Co., Inc., Rahway, NJ, USA (United States) · USPeking University · CNRenji Hospital · CNSichuan University · CNSun Yat-sen University · CNUlsan College · KRUniversity Malaya Medical Centre · MYZhejiang Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe evaluated the efficacy and safety of pembrolizumab in patients from Asia with previously treated advanced hepatocellular carcinoma (HCC).

methodsIn a double-blind, phase III trial, 453 patients with advanced HCC and progression during or after treatment with or intolerance to sorafenib or oxaliplatin-based chemotherapy were randomly assigned in a 2:1 ratio to receive pembrolizumab (200 mg) or placebo once every 3 weeks for ≤ 35 cycles plus best supportive care. The primary end point was overall survival (one-sided significance threshold,

resultsMedian overall survival was longer in the pembrolizumab group than in the placebo group (14.6

conclusionIn patients from Asia with previously treated advanced HCC, pembrolizumab significantly prolonged overall survival and PFS, and ORR was greater versus placebo.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodHumansAntibodies, Monoclonal, Humanizedpembrolizumab

Identifiers

PMID36455168
PMCPMC9995104
OpenAlexW4310595719

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.