- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04665609
Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC
2. marts 2021 opdateret af: Ping Liang, Chinese PLA General Hospital
Safety and Effectiveness of Thermal Ablation Combined With Anlotinib and TQB2450 Solution for Advanced Hepatocelualr Carcinoma
In this study, investigators aimed to evaluated the efficacy and safety of microwave ablation combined with anlotinib and TQB2450 Solution in patients with advanced hepatocellular carcinoma.
Patients were randomly assigned at a one-to-one ratio to receive microwave ablation plus anlotinib and TQB2450 Solution or microwave ablation plus TQB2450 Solution.
Primary end points were objective response rate(ORR).
Second end points include overall survival, progression-free survival and disease control rate.
Safety was assessed in all patients.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
80
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ping Liang
- Telefonnummer: +8601066939530 +8601066939530
- E-mail: liangping301@126.com
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100853
- Chinese PLA General Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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).
|
|
Aktiv komparator: 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.
|
TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ORR
Tidsramme: 2-year
|
Objective Response Rate
|
2-year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
OS
Tidsramme: 2-year
|
Overall Survival
|
2-year
|
|
PFS
Tidsramme: 2-year
|
Progression-free Survival
|
2-year
|
|
DCR
Tidsramme: 2-year
|
Disease Control Rate
|
2-year
|
|
EORTC QLQ C30
Tidsramme: Change from baseline health related quality of life at 2 years
|
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.
|
Change from baseline health related quality of life at 2 years
|
|
EORTC QLQ-HCC18
Tidsramme: Change from baseline health related quality of life at 2 years
|
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.
|
Change from baseline health related quality of life at 2 years
|
|
AE
Tidsramme: 2-year
|
Incidence of Adverse Events
|
2-year
|
|
SAEs
Tidsramme: 2-year
|
Incidence of Severe Adverse Events
|
2-year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
5. marts 2021
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
31. december 2023
Datoer for studieregistrering
Først indsendt
30. november 2020
Først indsendt, der opfyldte QC-kriterier
7. december 2020
Først opslået (Faktiske)
11. december 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 301jrcsk-lp-yj
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hepatocellulært karcinom
-
Xiangya Hospital of Central South UniversityIkke rekrutterer endnu
-
National Cancer Institute (NCI)AfsluttetMetastatisk blæreurothelial karcinom | Metastatisk Ureter Urothelial Carcinoma | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Metastatisk nyrebækken og Ureter Urothelial CarcinomaForenede Stater
-
Tyra Biosciences, IncRekrutteringLow Grade Upper Tract Urothelial CarcinomaForenede Stater
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Metastatisk Urothelial Carcinom | Lokalt avanceret blæreurothelial karcinom | Lokalt avanceret nyrebækken Urothelial Carcinoma | Lokalt... og andre forholdForenede Stater
-
Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.Trukket tilbageMetastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Uoperabelt nyrebækken Urothelial Carcinom | Uoperabelt Ureter Urothelial CarcinomaForenede Stater
-
All India Institute of Medical Sciences, New DelhiUkendtHOVED- OG NAKKEKRÆFT | CARCINOMA OROPHARYNX | CARCINOMA PYRIFORM SINUS | CARCINOMA LARYNXIndien
-
Changhai HospitalAktiv, ikke rekrutterendeNeoadjuverende terapi | Urothelial Carcinoma Ureter | Øvre urinvejsurothelial karcinomKina
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Cancer Research Institute, New York City; Fibrolamellar Cancer Foundation; Dracen Pharmaceuticals, Inc...Ikke rekrutterer endnuLeverkræft (Fibrolamellær Hepatocellular Kræft (FLC))Forenede Stater
-
Barbara Ann Karmanos Cancer InstituteBristol-Myers SquibbAfsluttetStadie III Blære Urothelial Carcinoma AJCC v6 og v7 | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Stadie II Blære Urothelial Carcinoma AJCC v6 og v7Forenede Stater
-
Sohag UniversityIkke rekrutterer endnuCarcinoma, Hepatocellulært
Kliniske forsøg med Anlotinib and TQB2450 solution
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtTredobbelt negativ brystkræft (TNBC)Kina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Ikke rekrutterer endnuSmåcellet lungekræft begrænset stadieKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtAvancerede solide tumorerKina
-
Jiangxi Provincial Cancer HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.RekrutteringSygdomme i fordøjelsessystemet | Gastrointestinale sygdomme | Neoplasmer efter histologisk type | Neoplasmer efter sted | Gastrointestinale neoplasmer | Neoplasmer i fordøjelsessystemet | Karcinom, pladecelle | Esophageale neoplasmer | Esophageale sygdomme | Neoplasmer, pladecelle | Esophageal pladecellekarcinomKina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RekrutteringStadie III Ikke-småcellet lungekræftKina
-
Fudan UniversityRekruttering
-
Xianhai MaoChia Tai Tianqing Pharmaceutical Group Co., Ltd.RekrutteringHepatocellulært karcinom | Adjuverende terapiKina
-
Tianjin Medical University Cancer Institute and...Rekruttering
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Rekruttering
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtGynækologisk kræftKina