- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04483284
Study of TACE Combined With Camrelizumab in the Treatment of HCC Patients
23 september 2021 uppdaterad av: Shanghai Zhongshan Hospital
Exploratory Clinical Study of TACE Combined With Camrelizumab in the Treatment of BCLC Stage B and Stage C Hepatocellular Carcinoma
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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: TACE combined with Camrelizumab
Camrelizumab(200mg q3w ivgtt)combined with TACE,the interval between TACE treatment and Carilizumab is not less than 7 days.
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Camrelizumab(200mg q3w ivgtt) combined with TACE
Andra namn:
Camrelizumab(200mg q3w ivgtt) combined with TACE
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression Free Survival
Tidsram: an expected average of 8 months
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the time from enrollment to the first disease progression or death from any cause
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an expected average of 8 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to progression
Tidsram: An expected average of 8 months
|
the time from enrollment to the first disease progression
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An expected average of 8 months
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Overall survival
Tidsram: An expected average of 24 months
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the time from enrollment to the death from any cause
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An expected average of 24 months
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Objective response rate
Tidsram: An expected average of 8 months
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evaluated by investigators with mRECIST
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An expected average of 8 months
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Disease control rate
Tidsram: An expected average of 8 months
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evaluated by investigators with mRECIST
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An expected average of 8 months
|
Duration of response
Tidsram: An expected average of 8 months
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evaluated by investigators with mRECIST
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An expected average of 8 months
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The incidence of AEs and SAEs by NCI-CTCAE v5.0
Tidsram: An expected average of 8 months
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Safety index
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An expected average of 8 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Yan zhiping, M.D., Shanghai Zhongshan Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 juni 2020
Primärt slutförande (Förväntat)
1 juli 2022
Avslutad studie (Förväntat)
1 december 2022
Studieregistreringsdatum
Först inskickad
20 juli 2020
Först inskickad som uppfyllde QC-kriterierna
22 juli 2020
Första postat (Faktisk)
23 juli 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 september 2021
Senast verifierad
1 september 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Adenocarcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i matsmältningssystemet
- Leversjukdomar
- Neoplasmer i levern
- Carcinom
- Karcinom, hepatocellulärt
- Läkemedels fysiologiska effekter
- Antineoplastiska medel
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Östrogener, icke-steroida
- Östrogener
- Klorotrianisen
Andra studie-ID-nummer
- MA-HCC-Ⅱ-003
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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