Evidence map›Paper›PMID 33586360›Full record

Trial reportCancer medicine2021

Anlotinib for previously treated advanced or metastatic esophageal squamous cell carcinoma: A double-blind randomized phase 2 trial.

Jing Huang, Juxiang Xiao, Wentao Fang, Ping Lu, Qingxia Fan, Yongqian Shu, Jifeng Feng, Shu Zhang, Yi Ba, Yang Zhao and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02649361 (A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Esophageal Squamous Cell Carcinoma), which is not on this map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
8.8field-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.

NCT02649361 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Esophageal Squamous Cell Carcinoma(ALTER1102)

TypeinterventionalSponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.Ran2016 to 2018Enrolled164ConditionsEsophageal Squamous Cell CarcinomaArmsAnlotinib, Placebo
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 115 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

16 authors at 13 institutions in 2 countries.

Jing HuangDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.ORCID 0000-0002-2167-8385
Juxiang XiaoDepartment of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Wentao FangDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Ping LuDepartment of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.
Qingxia FanDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Yongqian ShuDepartment of Medical Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.ORCID 0000-0003-3122-7139
Jifeng FengDepartment of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.
Shu ZhangDepartment of Medical Oncology, Shandong Cancer Hospital, Jinan, China.
Yi BaDepartment of Medical Oncology, Tianjin Cancer Hospital, Tianjin, China.
Yang ZhaoDepartment of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China.
Ying LiuDepartment of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China.
Chunmei BaiDepartment of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yuxian BaiDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Yong TangDepartment of Gastroenterology, Affiliated Tumor Hospital, Xinjiang Medical University, Urumqi, China.
Yan SongDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Jie HeDepartment of Thoracic Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNFirst Affiliated Hospital of Xinxiang Medical University · CNFirst Affiliated Hospital of Zhengzhou University · CNHarbin Medical University · CNHenan Cancer Hospital · CNJiangsu Cancer Hospital · CNJiangsu Province Hospital · CNNanjing Medical University · CNShandong Tumor Hospital · CNShanghai Jiao Tong University · CNTianjin Medical University Cancer Institute and Hospital · CNXinjiang Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrently, there are no randomized trials on the effect of antiangiogenic therapy in patients with esophageal squamous cell carcinoma (ESCC). The following study investigated the efficacy and safety of anlotinib in patients with advanced ESCC who were previously treated with chemotherapy.

methodsThis randomized, placebo-controlled, double-blind phase 2 trial (NCT02649361) was conducted in 13 Chinese hospitals. Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC who were previously treated with chemotherapy, and were randomly assigned (2:1) to receive oral anlotinib 12 mg or placebo on days 1-14 (repeated every 21 days). The primary endpoint was progression-free survival (PFS).

resultsOne hundred and sixty-five patients were randomly assigned to the anlotinib (n = 110) or the placebo (n = 55) arm. Median PFS was 3.02 months (95% CI 2.63-3.65) in the anlotinib group and 1.41 months (95% CI 1.38-1.41) in the placebo group (hazard ratio 0.46 [95% CI 0.32-0.66]; p < 0.001). The most common treatment-related adverse events of grade 3 or 4 were hypertension (17 [16%] patients), decreased appetite (6 [6%] patients), and hyponatremia (4 [4%] patients) in the anlotinib group and decreased appetite (2 [4%] patients) in the placebo group. Three (3%) deaths in the anlotinib group were considered as drug related, while there were no treatment-related deaths in the placebo group.

conclusionsThe use of anlotinib in previously treated, recurrent, or metastatic ESCC patients significantly improved PFS compared with placebo. Our findings suggest that antiangiogenesis might be an important therapeutic target in advanced ESCC. CLINICAL TRIALS REGISTRATION: Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102), NCT02649361.

Indexed as

AdultAgedAngiogenesis InhibitorsDouble-Blind MethodEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaFeeding and Eating DisordersFemaleHumansHypertensionHyponatremiaIndolesMaleMiddle AgedNeoplasm Recurrence, LocalPlacebosAngiogenesis InhibitorsanlotinibIndolesPlacebosQuinolinesadverse eventsanlotinibesophageal squamous cell carcinomametastaticprogression-free survival

Identifiers

PMID33586360
PMCPMC7940231
OpenAlexW3131270109

What OpenQuestion holds

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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.