Evidence map›Paper›PMID 34086067›Full record

Trial reportCancer chemotherapy and pharmacology2021

A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers.

Xiaoxue Zhu, Hongjie Qian, Jixuan Sun, Min Wu, Chen Yu, Yanhua Ding, Xiaodi Zhang, Katherine Chai, Xiaojiao Li

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2021. 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 32% 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.

NCT03483649 phase1completednot on this map

Randomized, Double Blind, Intravenous, Single Dose, Parallel, 4-arm Comparative Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus US-sourced Avastin®, EU-sourced Avastin®, and CN-sourced Avastin® in Healthy Male Subjects

TypeinterventionalSponsorShanghai Henlius BiotechRan2017 to 2017Enrolled208ConditionsHealthy Male SubjectsArmsHLX04, US-Avastin®, EU-Avastin®, CN-Avastin®
NCT03511963 phase3completednot on this map

A Randomized, Double-blind, Parallel Control, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of HLX04 and Bevacizumab Combined With Oxaliplatin and Fluoropyrimidine-based Chemotherapy (XELOX or mFOLFOX6) in the First-line Treatment of Metastatic Colorectal Cancer (mCRC)

TypeinterventionalSponsorShanghai Henlius BiotechRan2018 to 2023Enrolled677ConditionsMetastatic Colorectal Cancer (mCRC)ArmsHLX04 100 mg in 4 ml Injection, Avastin 100 mg in 4 ml Injection
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

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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

9 authors at 2 institutions in 1 country.

Xiaoxue Zhu *The First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China.
Hongjie Qian *Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai, China.
Jixuan SunThe First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China.
Min WuThe First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China.
Chen YuCentral Laboratory, Shanghai Xuhui Central Hospital, Shanghai, China.
Yanhua DingThe First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China.
Xiaodi ZhangShanghai Henlius Biotech, Inc., Shanghai, China.
Katherine ChaiShanghai Henlius Biotech, Inc., Shanghai, China.
Xiaojiao LiThe First Hospital of Jilin University, No. 1 Xinmin Street, Chaoyang District, Changchun, Jilin, China. xiaojiaoli@jlu.edu.cn.ORCID http://orcid.org/0000-0002-2936-7864
Jilin University · CNShanghai Xuhui Central Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the pharmacokinetic profiles, safety and immunogenicity of proposed bevacizumab biosimilar HLX04 with reference bevacizumab in healthy Chinese males.

methodsIn this double-blind Phase 1 study, healthy volunteers (N = 208) were randomized 1:1:1:1 to a single 3 mg/kg intravenous infusion of HLX04 or reference bevacizumab sourced from the United States (bevacizumab-US), the European Union (bevacizumab-EU) or China (bevacizumab-CN). Co-primary endpoints were area under the serum concentration-time profile (AUC) from time zero extrapolated to infinity (AUC

resultsPharmacokinetic parameters were similar across groups. The respective geometric least-squares mean ratios (GLSMR) of AUC

conclusionHLX04 had similar safety and pharmacokinetic profiles to reference bevacizumab in healthy Chinese males, supporting the confirmatory Phase 3 study investigating the efficacy and safety equivalence between HLX04 and bevacizumab in patients with metastatic colorectal cancer (NCT03511963). CLINICAL

trial registrationThe study was registered with Clinicaltrials.gov, NCT03483649.

Indexed as

Asian PeopleAdultAntineoplastic Agents, ImmunologicalArea Under CurveBevacizumabBiosimilar PharmaceuticalsChinaDouble-Blind MethodEuropean UnionHumansInfusions, IntravenousMaleMiddle AgedTherapeutic EquivalencyUnited StatesYoung AdultAntineoplastic Agents, ImmunologicalBevacizumabBiosimilar PharmaceuticalsBevacizumabBioequivalenceBiosimilarPharmacokinetics

Identifiers

PMID34086067
PMCPMC8316231
OpenAlexW3165886151

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.