- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07801287
Iparomlimab/Tuvonralimab Plus SBRT and Lenvatinib for Perioperative Treatment of Potentially Resectable Intermediate-Stage HCC
A Single-Arm, Single-Center Clinical Trial Evaluating Efficacy and Safety of Iparomlimab/Tuvonralimab Plus Stereotactic Body Radiation Therapy and Lenvatinib for Perioperative Treatment of Potentially Resectable Intermediate-Stage Hepatocellular Carcinoma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Maobin Meng
- Numero di telefono: 022-23340123
- Email: mmeng@tmu.edu.cn
Backup dei contatti dello studio
- Nome: Tianqiang Song
- Numero di telefono: 022-23340123
Luoghi di studio
-
-
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Tianjin, Cina
- Reclutamento
- Tianjin medical university institute & hospital
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Contatto:
- Maobin Meng
- Numero di telefono: 022-23340123
- Email: mmeng@tmu.edu.cn
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Able to understand and voluntarily sign the informed consent form for this study. · Age ≥18 years old, male and female. · Pathologically or clinically confirmed potentially resectable intermediate-stage hepatocellular carcinoma (stage IIIa). · ECOG performance status of 0-1; · Child-Pugh score <7. · No prior anti-tumor treatment; · Expected survival ≥3 months; · At least one measurable target lesion confirmed by imaging examination during the screening period, according to RECIST v1.1 criteria; · Adequate organ and bone marrow function within 7 days prior to the first administration of study drug.· If HBV or HCV infection is present, the patient must be receiving regular treatment.· Fertile eligible patients must agree to use reliable contraceptive methods with their partner during the trial and for at least 180 days after the last dose of study drug.
Exclusion Criteria:
- Unable to comply with the study protocol or study procedures;· Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma (mixed hepatocellular carcinoma), or other similar types; · Presence of extrahepatic metastatic lesions; · History of liver transplantation, or planned liver transplantation; · Evidence of central nervous system metastasis, and/or patients with carcinomatous meningitis; · History of hypersensitivity to the study drug or its formulation components, or known allergic diathesis; · Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); · Presence of ascites requiring clinical intervention, or uncontrolled pleural effusion, pericardial effusion of moderate or greater amount, etc., as confirmed by screening examinations; · History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first dose of study drug, or known severe varices on endoscopy within 3 months prior to the first dose of study drug; · Current interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease requiring corticosteroid treatment, or other pulmonary fibrosis or organizing pneumonia that may interfere with the assessment and management of immune-related pulmonary toxicity; · Obvious bleeding tendency or other evidence of significant coagulation disorders; · History of severe cardiovascular or cerebrovascular disease; · History of other malignancies within 5 years prior to enrollment, except for radically resected basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ; · Active autoimmune disease within 4 weeks prior to enrollment, or history of autoimmune disease; · Prior allogeneic bone marrow transplantation or organ transplantation; · Patients considered by the investigator to be unsuitable for enrollment in this study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Iparomlimab/Tuvonralimab plus SBRT and Lenvatinib
|
Iparomlimab/Tuvonralimab: Intravenous infusion of 7.5 mg/kg repeated every 21 days as one cycle. Administration for 2-3 cycles before sugery and continuously for one year after surgery. Lenvatinib: orally at a dose of 8 mg once daily (for patients with body weight <60 kg) or 12 mg once daily (for patients with body weight ≥60 kg), and taken continuously for one year after surgery. Stereotactic body radiation therapy: 40-45 Gy/5F, once daily, 1-2 weeks before Iparomlimab/Tuvonralimab. Surgery will be performed within 4-6 weeks after the last dose of conversion therapy, with a maximum of 12 weeks. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of TEAEs
Lasso di tempo: From date of randomization until the occurrence of adverse events assessed up to 24 months
|
including adverse events and their severity (classified according to CTCAE v5.0), frequency of occurrence, etc.
|
From date of randomization until the occurrence of adverse events assessed up to 24 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rate of R0 Resection
Lasso di tempo: From date of randomization until the completion of operation assessed about 6 months
|
The proportion of patients in whom the tumor is completely removed with no residual microscopic disease (negative surgical margins).
|
From date of randomization until the completion of operation assessed about 6 months
|
|
Event-Free Survival
Lasso di tempo: From date of randomization until disease progression, recurrence, death, or treatment failure assessed up to 24 months
|
The time from randomization to the occurrence of any predefined event, which may include disease progression, recurrence, death, or treatment failure.
|
From date of randomization until disease progression, recurrence, death, or treatment failure assessed up to 24 months
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Neoplasie per tipo istologico
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie del fegato
- Neoplasie, ghiandolari ed epiteliali
- Adenocarcinoma
- Neoplasie del fegato
- Carcinoma
- Carcinoma, epatocellulare
- Tecniche investigative
- Terapie
- Procedure chirurgiche, operative
- Radioterapia
- Tecniche stereotassiche
- Procedure neurochirurgiche
- Radiochirurgia
- Lenvatinib
Altri numeri di identificazione dello studio
- E20260375
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .