Evidence map›Paper›PMID 41823246›Full record

ArticleTechnology in cancer research & treatment

Evaluation of RC48-ADC in Combination with PRaG Regimen: An Open-Label, Prospective, Multicentre Study Assessing Efficacy and Safety for Advanced Refractory HER2-Expressing Solid Tumors (PRaG3.0 Study Protocol).

Meiling Xu, Yuehong Kong, Junjun Zhang, Rongzheng Chen, Pengfei Xing, Xiangrong Zhao, Shicheng Li, Yingying Xu, Liyuan Zhang, Li Zou

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Technology in cancer research & treatment. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05115500 (Antibody-Drug Conjugate Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment Advanced Refractory Solid Tumors With HER-2 Positive), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05115500 phase2unknown statusnot on this map

Antibody-Drug Conjugate Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment Advanced Refractory Solid Tumors With HER-2 Positive(PRaG3.0)

TypeinterventionalSponsorSecond Affiliated Hospital of Soochow UniversityRan2021 to 2025Enrolled55ConditionsCarcinoma, Solid TumorArmsADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

10 authors.

Meiling XuCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Yuehong KongCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Junjun ZhangCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Rongzheng ChenCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Pengfei XingCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Xiangrong ZhaoCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Shicheng LiCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Yingying XuCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Liyuan ZhangCenter of PRaG therapy, The Second Affiliated Hospital of Soochow University, Suzhou, China.ORCID 0000-0002-7469-1743
Li ZouCenter for Cancer Diagnosis and Treatment, The Second Affiliated Hospital of Soochow University, Suzhou, China.ORCID 0009-0004-5786-8430

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

IntroductionThis study aims to investigate the effectiveness and safety of combining the antibody-drug conjugate (ADC) disitamab vedotin (RC48) with the established PRaG regimen (PD-1 inhibitor, Radiotherapy, and GM-CSF) for treating HER2-expressing (IHC 3+, 2+, or 1+) advanced solid tumors. This novel PRaG3.0 regimen is hypothesized to leverage the tumor radiosensitizing and immunogenic cell death properties of ADCs to amplify the synergistic antitumor effects of radioimmunotherapy, offering a potential paradigm for pan-cancer therapy.MethodsThis study is a prospective, single-arm, open-label, multi-center clinical trial. Patients enrolled have confirmed HER2-expressing solid tumors (IHC 3+, 2+, or 1+) that have progressed after standard treatment or were intolerant to it. Patients received RC48 (2 mg/kg) via intravenous injection on day 1, followed by subcutaneous GM-CSF at 200 µg from days 3 to 7 and interleukin-2 (IL-2) at 2 million IU from days 8 to 12. Radiotherapy was initiated on day 3, targeting one lesion with hypofractionated radiotherapy (2-3 fractions of 5 or 8 Gy). PD-1/PD-L1 antibodies were administered within one week after completing radiotherapy. Treatment was repeated every three weeks, and if there were no target lesions, radiotherapy could be discontinued, with RC48 given for at least six cycles. After achieving a complete tumor response, maintenance therapy with PD-1/PD-L1 antibodies continued until disease progression or intolerable toxicity occurred. The primary endpoint was the objective response rate (ORR).ResultsThe study is currently in the recruitment phase (Registration No: NCT05115500). The primary endpoint is the objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety, and QoL. Planned enrollment is 62 patients.ConclusionThe PRaG3.0 protocol represents an innovative approach combining ADC therapy with radioimmunotherapy to address HER2-expressing cancers, including those with HER2-low expression. If successful, this regimen could establish a highly effective combination strategy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesImmunoconjugatesNeoplasmsAdultAgedClinical Trials, Phase II as TopicFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansMaleMiddle AgedMulticenter Studies as TopicProspective StudiesRadioimmunotherapyTreatment OutcomeERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesGranulocyte-Macrophage Colony-Stimulating FactorImmunoconjugatesadvanced refractory solid tumorsantibody-drug conjugatesHER2-low expressionhuman epidermal growth factor receptor 2radioimmunotherapy

Identifiers

PMID41823246
PMCPMC12988272

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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.