Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC
Safety and Effectiveness of Thermal Ablation Combined With Anlotinib and TQB2450 Solution for Advanced Hepatocelualr Carcinoma
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Anticipato)
Iscrizione
Fase
Fase
- Fase 3
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Ping Liang
- Numero di telefono: +8601066939530 +8601066939530
- Email: liangping301@126.com
Luoghi di studio
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Beijing
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Beijing, Beijing, Cina, 100853
- Chinese PLA General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- ECOG PS score: 0-1, Life expectancy of 3 months or more
- Subjects must have confirmed diagnosis of HCC
- BCLC B and C grade
- At least 1 measurable target lesion according to mRECIST
- Child-Pugh score A to B
- No locoregional therapy within 4 weeks before enrollment for patients with unresectable HCC or tumor progression after locoregional therapy; All toxicities related to prior treatments must be resolved to Grade ≤1
- No prior treatment with anti-angiogenic drugs or any anti-PD-1 agent within 4 weeks before enrollment
- HBV DNA<500IU/mL
- Adequate organ function within 14 days before enrollment
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of study drug. Women must not be breastfeeding. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
Exclusion Criteria:
- Prior liver transplant
- Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control
- Prior treatment with an anti-PD-L1
- Active autoimmune disease that has required systemic treatment in past 2 years
- Known or suspected allergy to Anlotinib and TQB2450 Solution or study drug components;History of severe hypersensitivity reaction to any monoclonal antibody
- Has received a live-virus vaccination within 30 days of planned treatment start.
- Subjects with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment
- Subjects with any active, known, or suspected autoimmune disease; Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- HBV DNA ≥ 1000 IU/ml,HCV RNA
- New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months, Prolongation of QTc (Fridericia formula) interval to >480 ms
- Dysfunction of blood coagulation (INR>1.5 or APTT>1.5×ULN), Bleeding or thrombotic disorders
- Anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Antiplatelet agents and low molecular weight heparin are prohibited throughout the study
- Active infection (any infection requiring systemic treatment)
- History of solid organ or hematologic transplant
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: Anlotinib and TQB2450 solution
Microwave ablation will be performed according to patients' tumor number, size and liver function.
Oral anlotinib (12 mg/d) will be administered and its cycle is defined as 2 weeks on-treatment followed by 1 week off-treatment.
Patients will be given 1200 mg TQB245 solution intravenously every 3 weeks.
The treatment continues until disease progression or treatment intolerance.
Anlotinib and TQB2450 solution will be given after 2 weeks of microwave ablation procedure.
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Anlotinib is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling.
TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).
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Comparatore attivo: TQB2450 Solution
Microwave ablation will be performed according to patients' tumor number, size and liver function.
Patients will be given 1200 mg TQB245 solution intravenously every 3 weeks.TQB2450 solution will be given after 2 weeks of microwave ablation procedure.
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TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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ORR
Lasso di tempo: 2-year
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Objective Response Rate
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2-year
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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OS
Lasso di tempo: 2-year
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Overall Survival
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2-year
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PFS
Lasso di tempo: 2-year
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Progression-free Survival
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2-year
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DCR
Lasso di tempo: 2-year
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Disease Control Rate
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2-year
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EORTC QLQ C30
Lasso di tempo: Change from baseline health related quality of life at 2 years
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Impact of treatment on Health Related Quality of Life (HRQoL) for subjects treated using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
EORTC QLQ C30 scales were grouped and converted to score 0 to 100 according to the scoring manual; a higher score represents a more severe symptom or problem.
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Change from baseline health related quality of life at 2 years
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EORTC QLQ-HCC18
Lasso di tempo: Change from baseline health related quality of life at 2 years
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Impact of treatment on Health Related Quality of Life (HRQoL) for subjects treated using HCC-specific EORTC QLQ-HCC18 questionnaire.
EORTC QLQ-HCC18 scales were grouped and converted to score 0 to 100 according to the scoring manual; a higher score represents a more severe symptom or problem.
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Change from baseline health related quality of life at 2 years
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AE
Lasso di tempo: 2-year
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Incidence of Adverse Events
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2-year
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SAEs
Lasso di tempo: 2-year
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Incidence of Severe Adverse Events
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2-year
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Collaboratori e investigatori
Sponsor
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Inizio studio
Completamento primario (Anticipato)
Completamento primario
Completamento dello studio (Anticipato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 301jrcsk-lp-yj
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