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c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI

2. april 2021 opdateret af: Weijian Guo, Fudan University

Second-line Irinotecan Combined With Cetuximab (c-CetuIRI) Versus Second-line Irinotecan Three-line Irinotecan Plus Cetuximab (s-IRI-CetuIRI) in the Treatment of Oxaliplatin and 5-FU Phase II Clinical Study of Wild-type Advanced Colorectal Cancer With RAS Gene

The primary endpoint is to evaluate the progression-free survival (PFS).

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

This study was designed for patients with advanced bowel cancer after first-line LOHP and 5-FU treatment failure. The control group was treated with second-line CPT-11+C225. The study group used second-line CPT-11 single drug until the third line was CPT-11+C225. treatment. Referring to the previous literature data, the PFS of the second-line treatment of CPT-11+C225 is about 4 months. This study assumes that the total PFS time of C225 can be extended to 7 months after the failure of second-line CPT-11 treatment compared with the direct second-line combination. , set α = 0.05, β = 0.2, the expected enrollment time is 2 years, the follow-up time is 1 year, the 10% sample shedding rate, the total sample size is about 60 cases per group, a total of 120 cases.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Studiesteder

    • Shanghai
      • ShangHai, Shanghai, Kina, 200032
        • Rekruttering
        • Fudan University Cancer 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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Signing informed consent;
  2. Age is greater than or equal to 18 years old;
  3. Metastatic colorectal adenocarcinoma confirmed by tissue or cytopathology;
  4. First-line failure to use oxaliplatin combined with fluorouracil (with or without anti-angiogenic targeting drugs);
  5. One or more measurable lesions, the longest diameter of the spiral CT scan is at least 10 mm, and the diameter of the conventional CT scan is at least 20 mm (the solid tumor efficacy evaluation standard, RECIST standard, version 1.1);
  6. The Eastern Cancer Cooperative Group (ECOG) has a general status score of 0-2;
  7. The bone marrow capacity, liver and kidney function reached the following criteria within 7 days before screening:

    Absolute neutrophil count ≥ 1.5x109 / L; hemoglobin ≥ 9.0 g / dl; platelet count ≥ 80 x 109 / L; total bilirubin ≤ 1.5 times normal upper limit (ULN); alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN Alkaline phosphatase ≤ 3 x ULN; serum creatinine ≤ 1.5 x ULN;

  8. Women of childbearing age need to take effective contraception.
  9. RAS, B-RAF gene wild type

Exclusion Criteria:

  1. Previous use of irinotecan or anti-egfr therapy for advanced colorectal cancer (e.g. Cetuximab, panizumab, etc.);
  2. History of HIV infection or active chronic hepatitis b or c (high copy viral DNA);
  3. Patients with important organ failure or other important diseases: patients with serious heart disease including congestive heart failure, uncontrolled arrhythmia, angina requiring long-term medication, heart valve disease, myocardial infarction, pericardial effusion with obvious symptoms, and refractory hypertension;A history of severe neurological or psychiatric problems;Severe infection;Active disseminated intravascular coagulation
  4. Active severe clinical infection;
  5. Symptomatic brain or meningeal metastasis (unless the patient was treated for > for 6 months, had negative imaging results within 4 weeks prior to study entry, and had stable tumour-related clinical symptoms at study entry);
  6. Patients whose seizures require treatment (e.g. steroids or antiepileptic therapy);
  7. Receiving renal dialysis;
  8. Have a history of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma, except for those whose metastasis can be confirmed by pathology to be from other tumor sources;
  9. Chronic intestinal diseases, infectious intestinal diseases and intestinal obstruction;
  10. Drug abuse and medical, psychological or social conditions may interfere with patients' participation in studies or affect the assessment of their findings;
  11. Any unstable condition or condition that may endanger the safety and compliance of patients;
  12. Pregnant or lactating women;Having fertility but not taking adequate contraceptive measures;

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
Aktiv komparator: c-CetuIRI
Irinotecan combined with cetuximab
180 mg/m2, ivgtt d1,q2w
500 mg/m2, ivgtt d1,q2w
Eksperimentel: s-IRI-CetuIRI
single irinotecan first, then irinotecan plus cetuximab sequentially after PD
180 mg/m2, ivgtt d1,q2w
500 mg/m2, ivgtt d1,q2w

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PFS
Tidsramme: op til 8 uger
progressionsfri overlevelse
op til 8 uger

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ORR
Tidsramme: op til 8 uger
objektiv svarprocent
op til 8 uger
OS
Tidsramme: through study completion, an average of half year
overall survival
through study completion, an average of half year

Samarbejdspartnere og efterforskere

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

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)

1. oktober 2019

Primær færdiggørelse (Forventet)

1. januar 2022

Studieafslutning (Forventet)

1. november 2022

Datoer for studieregistrering

Først indsendt

12. oktober 2019

Først indsendt, der opfyldte QC-kriterier

2. april 2021

Først opslået (Faktiske)

6. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

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 .

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