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L'essai clinique NCT04483284 pour Carcinome hépatocellulaire est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Study of TACE Combined With Camrelizumab in the Treatment of HCC Patients
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT04483284 est conçu pour étudier le treatment de Carcinome hépatocellulaire. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : actif, pas en recrutement. L'essai a débuté le 24 juin 2020 et vise à recruter 28 participants. Dirigé par Shanghai Zhongshan Hospital, l'essai devrait être terminé d'ici le 1 mai 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 1 août 2024.
Résumé succinct
It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.
Description détaillée
This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.
Titre officiel
Exploratory Clinical Study of TACE Combined With Camrelizumab in the Treatment of BCLC Stage B and Stage C Hepatocellular Carcinoma
Conditions
Carcinome hépatocellulaireAutres identifiants de l'essai
- MA-HCC-Ⅱ-003
Numéro NCT
Date de début (réel)
2020-06-24
Dernière mise à jour publiée
2024-08-01
Date de fin (estimée)
2025-05
Inscription (estimée)
28
Type d'essai
Interventionnel
PHASE
Phase II
Statut
Actif, pas en recrutement
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalTACE combined with Camrelizumab Camrelizumab（200mg q3w ivgtt）combined with TACE,the interval between TACE treatment and Carilizumab is not less than 7 days. | TACE Combined with Camrelizumab Camrelizumab(200mg q3w ivgtt) combined with TACE TACE Plus Camrelizumab Camrelizumab(200mg q3w ivgtt) combined with TACE |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Progression Free Survival | the time from enrollment to the first disease progression or death from any cause | an expected average of 8 months |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Time to progression | the time from enrollment to the first disease progression | An expected average of 8 months |
Overall survival | the time from enrollment to the death from any cause | An expected average of 24 months |
Objective response rate | evaluated by investigators with mRECIST | An expected average of 8 months |
Disease control rate | evaluated by investigators with mRECIST | An expected average of 8 months |
Duration of response | evaluated by investigators with mRECIST | An expected average of 8 months |
The incidence of AEs and SAEs by NCI-CTCAE v5.0 | Safety index | An expected average of 8 months |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 1.Patients voluntarily entered the study and signed informed consent form (ICF) 2. Age: 18 - 80 years old and life expectancy of at least 12 weeks.; 3. Clinically or histologically diagnosed as HCC; 4. There are measurable lesions that meet the RECIST1.1 standard on the baseline imaging examination; 5. Child-pugh classification A or B (score < 7); 6. The BCLC stage is stage B or C, and it is unable or unwilling to undergo surgical treatment; 7. ECOG : 0 ~ 1 ; 8. No previous immune checkpoint inhibitor treatment (including PD-1 / PD-L1 antibody and CTLA-4 inhibitor); 9. HBV-deoxyribonucleic acid (DNA) must be <500IU / mL, and receive at least 14 days of anti-HBV treatment before the start of study treatment Treatment;
- 1. History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy; 2. Those whose tumor thrombus reaches or exceeds the main portal vein; 3. Existing or concurrently suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma; 4. There is any active autoimmune disease or has a history of autoimmune disease and may relapse; 5. Use strong CYP3A4 / CYP2C19 inducers including rifampicin and Hypericum perforatum or strong CYP3A4 / CYP2C19 inhibitors within 14 days before starting the study treatment; 6. Known history of severe allergy to any monoclonal antibody; 7. Patients who are going to undergo or have undergone organ or allogeneic bone marrow transplantation; 8. Non-compliance with TACE or Camrelizumab; 9. Moderate and severe ascites with clinical symptoms require therapeutic puncture, drainage, or Childa-Pugh score> 2 (except imaging only shows a small amount of ascites but not accompanied by clinical symptoms); uncontrolled or moderate and Above pleural effusion and pericardial effusion; 10. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of the study treatment; 11. Thrombosis or embolism occurred within 6 months before the start of study treatment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism, etc.) 12. Known inherited or acquired bleeding or thrombophilia ; currently or recently (10 days prior to the start of study treatment) have used full dose oral or Injection of anticoagulant drugs or thrombolytic drugs (prophylactic use of low-dose aspirin and low molecular weight heparin); 13. Major vascular disease within 6 months before the study treatment; 22. Past or present central nervous system metastasis; 14. Metastatic diseases involving major airways or blood vessels or a large mediastinal tumor mass in the center (<30 mm from the crest) 15. Those with a history of hepatic encephalopathy; 16. Palliative radiotherapy for non-target lesions allowed for symptom control must be completed at least 2 weeks before the start of study treatment. Adverse events caused by radiotherapy have not recovered to ≤CTCAE level 1; 17. There were severe infections within 4 weeks before starting the study treatment; 18. Patients with congenital or acquired immune deficiency (such as those infected with HIV); 19. Co-infection with hepatitis B and C; 20. For patients with bone metastases, the palliative radiotherapy area> 5% bone marrow area received within 4 weeks before participating in the study;
Shanghai Zhongshan HospitalAucune donnée de contact disponible
1 Centres de l'essai dans 1 pays
Shanghai Municipality
Department of Interventional Radiology, Zhongshan Hospital, Fudan University., Shanghai, Shanghai Municipality, 200032, China