Evidence map›Paper›PMID 36882775›Full record

Trial reportBMC medicine2023

Comparing a PD-L1 inhibitor plus chemotherapy to chemotherapy alone in neoadjuvant therapy for locally advanced ESCC: a randomized Phase II clinical trial : A randomized clinical trial of neoadjuvant therapy for ESCC.

Yong Li, Aiping Zhou, Shuoyan Liu, Ming He, Keneng Chen, Ziqiang Tian, Yin Li, Jianjun Qin, Zhen Wang, Haiquan Chen and 16 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04460066 (A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection), which is not on this map. Cited by 40 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 9 pooled it
12.7field-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.

NCT04460066 phase1 / phase2unknown statusnot on this map

A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection (ZKAB001) Combined Albumin Binding Paclitaxel, Cisplatin in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma.

TypeinterventionalSponsorLee's Pharmaceutical LimitedRan2020 to 2023Enrolled70ConditionsEsophageal CancerArmsanti-PD-L1 antibody, albumin bound paclitaxel, cisplatin, placebo, radical resection of esophageal carcinoma
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 9 syntheses or guidelines pooled it, 40 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

26 authors at 7 institutions in 2 countries.

Yong Li *Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Aiping Zhou *Department 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, 100021, China.
Shuoyan LiuFujian Provincial Cancer Hospital, Fujian, China.
Ming HeThe Fourth Hospital of Hebei Medical University, Hebei, China.
Keneng ChenPeking University Cancer Hospital, Beijing, China.
Ziqiang TianThe Fourth Hospital of Hebei Medical University, Hebei, China.
Yin LiDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Jianjun QinDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Zhen WangDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Haiquan ChenFudan University Cancer Hospital, Shanghai, China.
Hui TianQilu Hospital of Shandong University, Shandong, China.
Yue YuClinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Wang QuDepartment 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, 100021, China.
Liyan XueDepartment of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Shun HeDepartment of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Shuhang WangClinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Fenglong BieDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Guangyu BaiDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Bolun ZhouDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Zhaoyang YangDepartment of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Huiyao HuangClinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Yan FangPET-CT Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Benjamin LiLee's Pharmaceutical Limited, Shenzhen, China.
Xiangrong DaiLee's Pharmaceutical Limited, Shenzhen, China.
Shugeng GaoDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China. gaoshugeng@cicams.ac.cn.ORCID 0000-0003-4211-552X
Jie HeDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, NO. 17, Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNHebei Medical University · CNLee's Pharmaceutical (China) · CNFudan University Shanghai Cancer Center · CNFujian Provincial Cancer Hospital · CNPeking University · CNQilu Hospital of Shandong University · CN

Funding

Beijing Natural Science Foundation 7222153Central Health Research Key Projects 2022ZD17Medical and Health Science-Technology Innovation Project of the Chinese Academy of Medical Sciences 2021-I2M-1-015National Key R&D Program of China 2021YFC2500900National Natural Science Foundation of China 82273129Research Project of the Institute LC2019L01
6 · The paper itself

Abstract

backgroundA Phase II study was undertaken to evaluate the safety and efficacy of the neoadjuvant socazolimab, a novel PD-L1 inhibitor, in combination with nab-paclitaxel and cisplatin for locally advanced esophageal squamous cell carcinoma (ESCC).

methodsSixty-four patients were randomly divided between the Socazolimab + nab-paclitaxel + cisplatin (TP) arm (n = 32) and the control arm (n = 32), receiving either socazolimab (5 mg/kg intravenously (IV), day 1) or a placebo with nab-paclitaxel (125 mg/m

resultsA total of 29 (90.6%) patients in each arm underwent surgery, and 29 (100%) and 28 (98.6%) patients underwent R0 resection in the Socazolimab + TP and Placebo + TP arms, respectively. The MPR rates were 69.0 and 62.1% (95% Confidence Interval (CI): 49.1-84.0% vs. 42.4-78.7%, P = 0.509), and the pCR rates were 41.4 and 27.6% (95% CI: 24.1-60.9% vs. 13.5-47.5%, P = 0.311) in the Socazolimab + TP and Placebo + TP arms, respectively. Significantly higher incidence rates of ypT0 (37.9% vs. 3.5%; P = 0.001) and T downstaging were observed in the Socazolimab + TP arm than in the Placebo + TP arm. The EFS and OS outcomes were not mature.

conclusionsThe neoadjuvant socazolimab combined with chemotherapy demonstrated promising MPR and pCR rates and significant T downstaging in locally advanced ESCC without increasing surgical complication rates.

trial registrationRegistration name (on clinicaltrials.gov): A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma. REGISTRATION NUMBER: NCT04460066.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaCisplatinHumansImmune Checkpoint InhibitorsNeoadjuvant TherapyCisplatinImmune Checkpoint InhibitorsChemotherapyEsophageal squamous cell carcinoma (ESCC)Major pathological response (MPR)Neoadjuvant treatmentPD-L1

Identifiers

PMID36882775
PMCPMC9993718
OpenAlexW4323531373

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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.