Evidence map›Paper›PMID 39500883›Full record

Trial reportNature communications2024

Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study.

Hairong Xu, Yong Zhou, Li Liang, Jingnan Shen, Wangjun Yan, Jin Wang, Jianmin Li, Xiaojing Zhang, Gang Huang, Wenzhi Bi and 20 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04255576 (A Phase Ib/II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of JMT103 in Surgically Unsalvageable or Refractory Giant Cell Tumor of Bone), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT04255576 phase1 / phase2unknown statusnot on this map

A Phase Ib/II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of JMT103 in Surgically Unsalvageable or Refractory Giant Cell Tumor of Bone

TypeinterventionalSponsorShanghai JMT-Bio Inc.Ran2019 to 2023Enrolled139ConditionsGiant Cell Tumor of BoneArmsDietary Supplement: Calcium/Vitamin D
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Observational
  4. Article
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

30 authors.

Hairong XuDepartment of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China.
Yong ZhouDepartment of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.
Li LiangDepartment of Medical Oncology and Radiation Sickness, Peking University Third Hospital, Beijing, China.
Jingnan ShenDepartment of Musculoskeletal Oncology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.ORCID 0000-0001-7471-2746
Wangjun YanDepartment of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.ORCID 0000-0001-9178-0687
Jin WangDepartment of Musculoskeletal Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Jianmin LiDepartment of Orthopedic Oncology, Qilu Hospital of Shandong University, Jinan, China.
Xiaojing ZhangDepartment of Bone and Soft Tissue Surgery, Liaoning Cancer Hospital and Institute, Shenyang, China.
Gang HuangDepartment of Bone and Soft Tissue Surgery, Hunan Cancer Hospital, Changsha, China.
Wenzhi BiSenior Department of Orthopedics, The Fourth Medical Center, Chinese PLA General Hospital, Beijing, China.
Zheng GuoDepartment of Orthopedics, The Second Affiliated Hospital of Air Force Medical University, Xi'an, China.
Yanbin XiaoThe Second Department of Orthopedic Surgery, Yunnan Cancer Hospital, Kunming, China.
Jianhua LinDepartment of Orthopedics, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
Weitao YaoDepartment of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Zhichao TongDepartment of Bone Tumor, Honghui Hospital, Xi'an Jiaotong University, Xi'an, China.
Wenxian ZhouDepartment of Breast, Bone and Soft Tissue Oncology, Guangxi Medical University Cancer Hospital, Nanning, China.
Guochuan ZhangDepartment of Bone and Soft Tissue Tumor, The Third Hospital of Hebei Medical University, Shijiazhuang, China.
Zhaoming YeDepartment of Orthopedics, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Dong WangDepartment of Orthopedics, Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China.
Jilong YangDepartment of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.ORCID 0000-0001-5162-3740
Zhengfu FanDepartment of Bone and Soft Tissue Tumor, Peking University Cancer Hospital, Beijing, China.
Caigang LiuDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China.ORCID 0000-0003-2083-235X
Guofan QuDepartment of Orthopedic Surgery, Harbin Medical University Cancer Hospital, Harbin, China.
Qing ZhangDepartment of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China.
Feng WeiDepartment of Medical Oncology and Radiation Sickness, Peking University Third Hospital, Beijing, China.
Weifeng LiuDepartment of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-6935-3064
Chongqi TuDepartment of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.
Hong LiCSPC Pharmaceutical Group Limited, Shijiazhuang, China.
Jing YuanCSPC Pharmaceutical Group Limited, Shijiazhuang, China.
Xiaohui NiuDepartment of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China. niuxiaohui@263.net.ORCID 0000-0001-7782-6669

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This was a multicenter, single-arm, open-label, phase Ib/II study (NCT04255576), aimed to evaluate the efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone (GCTB). JMT103 (2 mg/kg) was administered subcutaneously every four weeks, with loading doses on days 8 and 15. The primary endpoint was the objective tumor response rate (OTR) based on best response, defined as the proportion of patients who achieved elimination of at least 90% of the giant cells or radiologic complete or partial response per the modified Inverse Choi density/size (mICDS) or modified European Organization for Research and Treatment of Cancer (mEORTC) within 12 weeks. Secondary endpoints included objective response rate (ORR) per mICDS and mEORTC, and safety. A total of 139 patients were enrolled, and 135 were analyzed for efficacy. OTR, determined by the independent review committee (IRC) was 93.3% (95% CI 87.7-96.9). Treatment-related adverse events occurred in 90 (64.7%) patients, with hypophosphatemia and hypocalcemia being the most common. No serious treatment-related adverse events were observed. Thus, JMT103 demonstrates potential as a therapeutic option for GCTB.

Indexed as

Bone NeoplasmsGiant Cell Tumor of BoneAdolescentAdultAgedAntineoplastic AgentsFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultAntineoplastic Agents

Identifiers

PMID39500883
PMCPMC11538294

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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.