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Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer

8. januar 2022 opdateret af: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Efficacy Evaluation of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer and Analysis of Dominant Population Characteristics and Methylation Characteristics

This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer. Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients. DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

200

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100053
        • Rekruttering
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
        • Kontakt:
        • Kontakt:

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
  2. TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
  3. Expected survival time is over 3 months.
  4. The age of 18 years old or more.
  5. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
  6. Chemotherapy and/or targeted therapy are planned.
  7. Signed informed consent.

Exclusion Criteria:

  1. History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
  2. Combined with severe heart, liver, lung and kidney disease.
  3. Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
  4. Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
  5. The expected survival time is less than 3 months.
  6. The researchers determine that they were not suitable for the study.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental Group
The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Medicin: Jianpi Huatan dispensing granule
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Placebo komparator: Control Group
The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Medicin: Placebo granule
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
From enrollment until disease progression or death
From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Tidsramme: From date of randomization until the date of death from any cause, assessed up to 100 months
From enrollment until death or end of the follow-up
From date of randomization until the date of death from any cause, assessed up to 100 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Survival rate
Tidsramme: 3 years
The 1-year, 2-year and 3-year survival rates of patients in the treatment group and the control group were analyzed
3 years
Disease control rate
Tidsramme: 3 months
Efficacy was assessed according to RECIST 1.1 at the end of 3 months of treatment.
3 months
Cancer fatigue score
Tidsramme: 3 months
Piper Fatigue Scale will be used.The fatigue of patients will be evaluated from 22 items of behavioral dimension, emotional dimension, sensory dimension and cognitive dimension. The higher the score of each dimension, the more serious the fatigue degree.
3 months
Traditional Chinese Medicine(TCM )symptom grading table
Tidsramme: 3 months

Effective: after treatment, TCM symptom score decreased by more than 50% compared with that before treatment.

Effective: decrease < 50% and equal to 30%; Invalid: decrease < 30%. Note: the formula is: (before treatment - integral after treatment) / before treatment by 100%.
3 months
The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale
Tidsramme: 3 months
The raw scores for the scales and single items were linearly transformed to values between 0 and 100 as described in the EORTC QLQ scoring manual. The mean and standard deviation of each scale/single item were calculated. A higher score for a functioning scale represented a healthier level of functioning, a higher score for the global health status scale represented a higher QOL, and a higher score for a symptom scale/item represented a worse level of symptomatology.
3 months
the United States Eastern Oncology Collaboration Group (ECOG) score scale
Tidsramme: 3 months
ECOG scoring standard is an indicator of patients' general health status and tolerance to treatment based on their physical strength. ECOG physical condition rating standard score 0-5 points. A minimum score of 0 indicates normal activity, a higher score indicates less physical activity, and a score of 5 indicates death.
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Samarbejdspartnere

Guang'anmen Hospital of China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences

Efterforskere

  • Studiestol: Yu Wu, Master, Xiyuan Hospital of China Academy of Chinese Medical Sciences

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 (Faktiske)

15. november 2021

Primær færdiggørelse (Forventet)

1. juli 2024

Studieafslutning (Forventet)

1. juli 2024

Datoer for studieregistrering

Først indsendt

20. december 2021

Først indsendt, der opfyldte QC-kriterier

8. januar 2022

Først opslået (Faktiske)

11. januar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2022

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CI2021A01803

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