Evidence map›Paper›PMID 36261583›Full record

Trial reportBritish journal of cancer2022

Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial.

Shukui Qin, Jin Li, Haijun Zhong, Chuan Jin, Lili Chen, Xianglin Yuan, Qingxia Fan, Kehe Chen, Peiguo Cao, Jianjun Xiao and 9 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03941574 (A Single-arm, Multi-center, Phase Ⅱ Clinical Study to Evaluate the HLX10 Monotherapy for the Treatment of Unresectable or Metastatic Microsatellite Instability-high), which is not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
4.0field-weighted citation impact, top 5% 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.

NCT03941574 phase2unknown statusnot on this map

A Single-arm, Multi-center, Phase Ⅱ Clinical Study to Evaluate the HLX10 Monotherapy for the Treatment of Unresectable or Metastatic Microsatellite Instability-high (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors That Failed to Respond to Standard Therapy

TypeinterventionalSponsorShanghai Henlius BiotechRan2019 to 2026Enrolled108ConditionsMSI-H Solid Malignant TumorArmsHLX10
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 15 institutions in 1 country.

Shukui Qin *Department of Oncology, Qinhuai Medical Area, Eastern Theater General Hospital of PLA China, Nanjing, China.
Jin Li *Department of Oncology, Tongji University Shanghai East Hospital, Shanghai, China. lijin@csco.org.cn.ORCID http://orcid.org/0000-0003-0099-874X
Haijun ZhongDepartment of Abdominal Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.
Chuan JinDepartment of Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.
Lili ChenDepartment of Hematology and Oncology, Taizhou First People's Hospital, Taizhou, China.
Xianglin YuanDepartment of Oncology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China.
Qingxia FanDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Kehe ChenDepartment of Oncology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
Peiguo CaoDepartment of Oncology, The Third Xiangya Hospital of Central South University, Changsha, China.
Jianjun XiaoChemotherapeutic Department, Zhongshan City People's Hospital, Zhongshan, China.
Da JiangDepartment of Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Tao ZhangDepartment of Oncology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Hongyu ZhangCancer Center, The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai, China.
Xicheng WangDepartment of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China.
Wei WangDepartment of Gastrointestinal Oncology, The First People's Hospital of Foshan, Foshan, China.
Lin HanShanghai Henlius Biotech, Inc., Shanghai, China.
Qingyu WangShanghai Henlius Biotech, Inc., Shanghai, China.
Jun ZhuShanghai Henlius Biotech, Inc., Shanghai, China.
Serplulimab-MSI-H Investigators
Central South University · CNChinese PLA General Hospital · CNFirst Affiliated Hospital of Guangdong Pharmaceutical University · CNFirst Affiliated Hospital of Zhengzhou University · CNFirst People's Hospital of Foshan · CNGuangzhou Medical University · CNHebei Medical University · CNShanghai East Hospital · CNSun Yat-sen University · CNTaizhou First People's Hospital · CNThe Affiliated Yongchuan Hospital of Chongqing Medical University · CNThe People's Hospital of Guangxi Zhuang Autonomous Region · CNTongji Hospital · CNZhejiang Cancer Hospital · CNZhongshan People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMicrosatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) tumours have a high response rate to immunotherapy. Antitumour activity and safety of serplulimab, a novel humanised anti-PD-1 monoclonal antibody, were evaluated in this phase II study.

methodsIn this ongoing, single-arm, open-label, phase II trial, patients with previously treated unresectable or metastatic MSI-H/dMMR solid tumours received intravenous serplulimab 3 mg/kg every 2 weeks for up to 52 cycles. The primary endpoint was objective response rate (ORR) assessed by an independent radiological review committee per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included additional efficacy measures, safety, and tolerability.

resultsAs of 9 January 2021, 108 patients were enrolled, and 68 patients with confirmed MSI-H solid tumours were included in the main efficacy analysis population (MEAP). The median follow-up duration in the MEAP was 7.7 months, with an ORR of 38.2% (95% confidence interval, 26.7-50.8). Of the 108 patients, grade ≥3 treatment-emergent adverse events were reported in 53 (49.1%) patients; immune-related adverse events occurred in 52 (48.1%) patients.

conclusionsSerplulimab demonstrates a durable antitumour effect and a manageable safety profile in previously treated patients with MSI-H solid tumours. Serplulimab is a promising tissue-agnostic treatment for previously treated MSI-H solid tumours.

trial registrationNCT03941574.

Indexed as

Antibodies, MonoclonalNeoplasmsHumansAntibodies, Monoclonal

Identifiers

PMID36261583
PMCPMC9726893
OpenAlexW4306770612

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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.