- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05453383
Clinical Recruitment of Patients With First-line Targeted Drug Resistance or Intolerance to Hepatocellular Cancer With PD-1 Inhibitor (Toripalimab,JS001) Detected on the NGS Platform Combined With Anlotinib
7. juli 2022 opdateret af: Shen Feng
PD-1 inhibitors have become the standard treatment for advanced hepatocellular cancer, while targeted drugs such as sorafenib and lenvatinib are the first-line standard treatment for hepatocellular cancer.
Recent studies have shown that PD-1 inhibitors combined with targeted drugs can improve the efficacy of hepatocellular cancer.To clear the joint treatment in patients with advanced hepatocellular cancer (HCC) efficacy and evaluate its safety, we proposed to carry out the PD - 1 inhibitor (Toripalimab, JS001) joint anti-angiogenesis small molecules targeting drug anlotinib for clinical research,at the same time, based on joint solution of NGS platform testing to predict the curative effect, bring benefit for the long-term survival of patients with hepatocellular cancer (HCC).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zhengang Yuan, Ph.D
- Telefonnummer: 00862181887451
- E-mail: yuanzg@163.com
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200438
- Rekruttering
- Eastern hepatobilliary surgery hospital
-
Kontakt:
- Wu Dong, MD
- Telefonnummer: 0086-021-25070765
- E-mail: wuyuz@yahoo.com.cn
-
-
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 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histological or cytological diagnosis of hepatocellular cancer;
- At least one measurable lesion was assessed according to RECIST1.1 criteria.
- Age from 18 to 75,ECOG physical strength score reaches 0-2;
- After first-line targeted therapy, it was assessed as advanced or intolerant according to RECIST1.1 criteria.
- Child-pugh grade A or B for liver function;
- Bone marrow function was basically normal: neutrophils > 1.5x 10^9/L, platelets > 75 x10^9/L;
- Adequate renal reserve: creatinine <130 mol/L;
- Centerless dysfunction, chest pain (medically uncontrollable), no myocardial infarction within 12 months prior to study initiation;
- Estimated survival ≥3 months;
- Signed the informed consent.
Exclusion Criteria:
- Previous application of PD-1 inhibitor and anlotinib;
- Secondary malignant tumors or other tumors (except superficial skin cancer and localized low-grade malignant tumors) occurring within 3 years prior to the start of the study;
- Metastasis of the brain or meninges;
- Imaging findings indicated that the tumor was involved in important blood vessels or that the researchers had assessed that it might lead to fatal bleeding during follow-up;
- Bleeding events at any site ≥CTCAE level 3 occurred 4 weeks before medication, and there were unhealed wounds, ulcers or fractures;
- The time of occurrence of arteriovenous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within 6 months before enrollment;
- Untreated intestinal obstruction or subobstruction that cannot eat or affect systemic administration;
- Patients with active infection or other possible disorders receive inflammatory infections under planned management;
- Have a history of uncontrolled substance abuse or mental disorders;
- In the judgment of the investigator, patients with concomitant diseases that may seriously endanger their own safety or may affect the completion of the study;
- Participated in other clinical trials;
- Pregnant and nursing women;
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Anlotinib and Toripalimab treatment
Anlotinib Hydrochloride and Toripalimab Injection
|
Anlotinib Hydrochloride;Toripalimab injiection
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective response rate
Tidsramme: at least 2 months
|
Objective response rate include response from stable disease to complete
|
at least 2 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival
Tidsramme: at least 2 months
|
The time between the start of randomization and tumorigenesis or death
|
at least 2 months
|
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)
8. juli 2022
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
31. december 2022
Datoer for studieregistrering
Først indsendt
7. juli 2022
Først indsendt, der opfyldte QC-kriterier
7. juli 2022
Først opslået (Faktiske)
12. juli 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EHBH-201908
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 Hepatocellulær kræft
-
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
Kliniske forsøg med Anlotinib;Toripalimab
-
Sun Yat-sen UniversityRekruttering
-
Qilu Hospital of Shandong UniversityIkke rekrutterer endnuLokalt avanceret eller metastatisk akralt malignt melanomKina
-
Shanghai Changzheng HospitalRekrutteringMavekræft | Immunterapi | Anlotinib | ToripalimabKina
-
Sun Yat-sen UniversityAfsluttetNasopharyngealt karcinom | Tilbagevendende eller metastatisk nasopharyngeal carcinomKina
-
Taizhou HospitalIkke rekrutterer endnuSCLC | Vedligeholdelsesbehandling
-
Hubei Cancer HospitalAfsluttet
-
Di WuIkke rekrutterer endnuUdifferentieret Pleomorphic Sarkom | Blødt vævssarkomKina
-
The First Affiliated Hospital of Zhengzhou UniversityIkke rekrutterer endnuAvanceret esophageal pladecellecarcinomKina
-
Third Military Medical UniversityRekrutteringSmåcellet lungekræft | Lungekræft | SCLC, omfattende faseKina
-
China Medical University, ChinaIkke rekrutterer endnu