Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
7. april 2021 oppdatert av: Zhong Wang
An Open-label, Single-institution, Non-randomized, Single-arm, Pilot Study of Jiu-wei-zhen-xiao Granule for the Treatment in Patients With Advanced Hepatocellular Carcinoma
This is a piolt single-arm trial of Jiu-wei-zhen-xiao Granule, extracted from nine kinds of Chinese medicnie, for the treatment in patients with advanced, unresectable hepatocellular carcinoma(HCC).
The primary objective is to assess its therapeutic efficacy in patients with unresectable HCC.
The primary endpoint is overall survival (OS) after the use of 12-week drug.
Secondary endpoints include progression-free survival (PFS) after the use of 12-week drug, the improvement of the score of the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), the changes of the liver function, coagulation function, the size of solid tumors,"Du-tan-yu-jie Zheng" in Chinese medicine, pain Visual Analogue Scale and toxicity profile of Jiu-wei-zhen-xiao Granule.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
10
Fase
- Tidlig fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hubei
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Wuhan, Hubei, Kina, 430061
- Hubei Provincial Hospital of Traditional Chinese Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age:18~75 years;
- Patients must have diagnosis of advanced hepatocellular cancer (HCC) by one of the following:
(1) Histopathology; (2) Elevated serum alpha-fetoprotein (AFP) >400 ng/ml and findings on magnetic resonance imaging (MRI) or computed tomography (CT) scans characteristic of HCC; (3) Findings on triple phase MRI or CT scans characteristic of HCC in patients with cirrhosis and tumors at least 1 cm or greater, without a curative treatment option (transplant, resection, or ablation).
3.The clinical staging of HCC is B or C or D staging as the Barceln Clinical Liver Cancer Classification(BCLC);
4. Patients with hepatitis B virus infection;
5. Patients with "Du-tan-yu-jie Zheng" in Chinese medicine;
6. Karnofsky score ≥60;
7. Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients with unstable vital signs;
- Any uncontrolled, severe, intercurrent illness including but not limited to ongoing or active infection, heart, brain, lung and other systemic diseases or other kinds of tumors;
- Known history of allergy to the ingredients of this product;
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment;
- Receipt of any other investigational agents ≤ 1 month of the first dose of study treatment;
- Patients who cannot take oral medication.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Jiu-wei-zhen-xiao Granule
Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.
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Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Overall Survival
Tidsramme: Up to 12 weeks
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Overall Survival (OS) is defined as the percentage of people in a group who are alive after the 12-week use of drug.
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Up to 12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Progression-Free Survival
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks
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Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier.
For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .
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Baseline, 4 weeks, 8 weeks, 12 weeks
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European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) (Chinese version, Version 3.0)
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks
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EORTC QLQ-C30 is a 30-item questionnaire composed of multi-item scales and single items that reflect the multidimensionality of the QoL construct.
It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), and a global health status/QoL scale.
The remaining single items assess additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), as well as the perceived financial impact of the disease and treatment.
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Baseline, 4 weeks, 8 weeks, 12 weeks
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The level of the liver function
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks
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The biochemical indicators of the liver function include alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin(TBiL), direct bilirubin (DBiL), albumin (ALB), alkaline phosphatase (AKP), gamma-Glutamyltransferase (γ-GGT).
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Baseline, 4 weeks, 8 weeks, 12 weeks
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The level of AFP
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks
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AFP is the abbreviation of alpha fetoprotein, which could be the progress of the primary hepatocellular carcinoma
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Baseline, 4 weeks, 8 weeks, 12 weeks
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The level of coagulation function
Tidsramme: Baseline, 12 weeks
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The biochemical indicators of the coagulation function include prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).
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Baseline, 12 weeks
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The size of solid tumors
Tidsramme: Baseline, 12 weeks
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The size of solid tumors is measured by a professional film reader using MRI/CT.
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Baseline, 12 weeks
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"Du-tan-yu-jie Zheng" symptoms score in Chinese medicine
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks
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"Du-tan-yu-jie Zheng" is a series of common symptoms in HCC，including distending pain in the hypochondrium,jaundice, a lump below the costal region,weak and lassitude, poor appetite,abdominal distension and fullness,dizziness and tinnitus, bitter or dry mouth,constipation, urinary yellow,upset and irritable,red or dark red tongue, stringy or rapid pulse
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Baseline, 4 weeks, 8 weeks, 12 weeks
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10cm-VAS of the pain
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks
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The 10cm Visual Analogue Scale (VAS) of the pain is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10) .
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Baseline, 4 weeks, 8 weeks, 12 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. april 2019
Primær fullføring (Faktiske)
24. juli 2020
Studiet fullført (Faktiske)
30. mars 2021
Datoer for studieregistrering
Først innsendt
21. februar 2019
Først innsendt som oppfylte QC-kriteriene
21. februar 2019
Først lagt ut (Faktiske)
22. februar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JIUWEI-Gan 1-Ver1.0
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