- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Maobin Meng
- Numéro de téléphone: 022-23340123
- E-mail: mmeng@tmu.edu.cn
Sauvegarde des contacts de l'étude
- Nom: Tianqiang Song
- Numéro de téléphone: 022-23340123
Lieux d'étude
-
-
-
Tianjin, Chine
- Recrutement
- Tianjin medical university institute & hospital
-
Contact:
- Maobin Meng
- Numéro de téléphone: 022-23340123
- E-mail: mmeng@tmu.edu.cn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of TEAEs
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of R0 Resection
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies du foie
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs du foie
- Carcinome
- Carcinome hépatocellulaire
- Techniques d'investigation
- Thérapeutique
- Procédures chirurgicales, opératoires
- Radiothérapie
- Techniques stéréotaxiques
- Procédures neurochirurgicales
- Radiochirurgie
- lenvatinib
Autres numéros d'identification d'étude
- E20260375
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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