Evidence map›Paper›PMID 38031088›Full record

Trial reportBMC medicine2023

A pilot study of multi-antigen stimulated cell therapy-I plus camrelizumab and apatinib in patients with advanced bone and soft-tissue sarcomas.

Yan Zhou, Mei Li, Bing Zhang, Cheng Yang, Yaling Wang, Shuier Zheng, Lina Tang, Chenliang Zhou, Guowei Qian, Yujing Huang and 10 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
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 NCT04074564 (An Exploratory Study Evaluating the Safety and Efficacy of MASCT-I Combined With Apatinib Mesylate and/or Camrelizumab in the Treatment of Patients With Advanced Bone and Soft Tissue Sarcoma), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
4.6field-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.

NCT04074564 early_phase1unknown statusnot on this map

An Exploratory Study Evaluating the Safety and Efficacy of MASCT-I Combined With Apatinib Mesylate and/or Camrelizumab in the Treatment of Patients With Advanced Bone and Soft Tissue Sarcoma

TypeinterventionalSponsorHRYZ Biotech Co.Ran2019 to 2024Enrolled60ConditionsSarcomaArmsMASCT-I, Camrelizumab,Apatinib
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
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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

20 authors at 5 institutions in 1 country.

Yan Zhou *Department of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Mei Li *Department of Radiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Bing ZhangDepartment of Orthopedic Oncology, the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Jiangxi, China.
Cheng YangDepartment of Orthopedic Oncology, Changzheng Hospital of Naval Military Medical University, Shanghai, China.
Yaling WangDepartment of Oncology, Shanghai Eighth People's Hospital, Shanghai, China.
Shuier ZhengDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Lina TangDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Chenliang ZhouDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Guowei QianDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Yujing HuangDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Wenxi YuDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Hongtao LiDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Yonggang WangDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Aina HeDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Zan ShenDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Jianjun ZhangDepartment of Oncology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. robustzhang168@aliyun.com.
Xiaoshuang LiHRYZ Biotech Co, Shenzhen, China.
Qingcheng YangDepartment of Orthopedic, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China. tjyqc@163.com.
Haiyan HuDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China. xuri1104@163.com.
Yang YaoDepartment of Oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China. yangyao_6@hotmail.com.
Shanghai Jiao Tong University · CNShanghai Sixth People's Hospital · CNAffiliated Hospital of Jiangxi University of Traditional Chinese Medicine · CNShanghai Changzheng Hospital · CNTongren Hospital · CN

Funding

National Natural Science Foundation of China 82072967National Natural Science Foundation of China 82102866Science Foundation of Shanghai Sixth People's Hospital ynqn202114Shanghai Pujiang Program 21PJD051
6 · The paper itself

Abstract

backgroundCell-based  immunotherapy shows the therapeutic potential in sarcomas, in addition to angiogenesis-targeted tyrosine kinase inhibitor (TKI) and immune checkpoint inhibitor (ICI). Multi-antigen stimulated cell therapy-I (MASCT-I) technology is a sequential immune cell therapy for cancer, which composes of multiple antigen-loaded dendritic cell (DC) vaccines followed by the adoptive transfer of anti-tumor effector T-cells.

methodsIn this phase 1 study, we assessed MASCT-I plus camrelizumab (an ICI against PD-1) and apatinib (a highly selective TKI targeting VEGFR2) in patients with unresectable recurrent or metastatic bone and soft-tissue sarcoma after at least one line of prior systemic therapy. One MASCT-I course consisted of 3 DC subcutaneous injections, followed by 3 active T cell infusions administered 18-27 days after each DC injection. In schedule-I group, 3 DC injections were administered with a 28-day interval in all courses; in schedule-II group, 3 DC injections were administered with a 7-day interval in the first course and with a 28-day interval thereafter. All patients received intravenous camrelizumab 200 mg every 3 weeks and oral apatinib 250 mg daily.

resultsFrom October 30, 2019, to August 12, 2021, 19 patients were enrolled and randomly assigned to schedule-I group (n = 9) and schedule-II group (n = 10). Of the 19 patients, 11 (57.9%) experienced grade 3 or 4 treatment-related adverse events. No treatment-related deaths occurred. Patients in schedule-II group showed similar objective response rate (ORR) with those in schedule-I group (30.0% versus 33.3%) but had higher disease control rate (DCR; 90.0% versus 44.4%) and longer median progression-free survival (PFS; 7.7 versus 4.0 months). For the 13 patients with soft-tissue sarcomas, the ORR was 30.8%, DCR was 76.9%, and median PFS was 12.9 months; for the 6 patients with osteosarcomas, the ORR was 33.3%, the DCR was 50.0%, and median PFS was 5.7 months.

conclusionsOverall, MASCT-I plus camrelizumab and apatinib was safe and showed encouraging efficacy in advanced bone and soft-tissue sarcoma, and schedule-II administration method was recommended.

trial registrationClinicalTrials.gov, NCT04074564.

Indexed as

SarcomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansPilot ProjectsProtein Kinase InhibitorsPyridinesAntibodies, Monoclonal, HumanizedapatinibcamrelizumabProtein Kinase InhibitorsPyridinesApatinibCamrelizumabCell-based immunotherapyMASCT-ISarcoma

Identifiers

PMID38031088
PMCPMC10687909
OpenAlexW4389137925

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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.