Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy

26. august 2021 opdateret af: Tao Zhang, Wuhan Union Hospital, China

A Prospective, Multicenter, Randomized Controlled Study of Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy

The study is a multicenter, open-label, randomized controlled clinical study. The purpose of the study is to evaluate the efficacy and safety of apatinib combined with chemotherapy versus chemotherapy in second-line gastric cancer receiving prior anti-PD-1 therapy.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

60 patients who meet the inclusion criteria will receive apatinib combine with chemotherapy or chemotherapy until the disease progresses or intolerable.

Apatinib: initial dose: 500mg,oral,once a day, after meal (try to take the medicine at the same time each day)

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 4

Kontakter og lokationer

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

Studiekontakt

  • Navn: Tao Zhang, Doctor
  • Telefonnummer: (+86)18971656660
  • E-mail: 1277577866@qq.com

Studiesteder

    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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. Age: ≥18 years old, Female or Male;
  2. Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
  3. Failure or intolerance of first-line chemotherapy which requires that the first-line chemotherapy regimen include the scheme based on anti-PD-1 drugs for no less than 2 months (Definition of treatment failure: intolerence of toxic side effects; disease progression during treatment; Or recurrence after the end of treatment.) Note: (1)The treatment of each line advanced disease includes one or more drugs with a medication time ≥ 1 cycle. (2) Early adjuvant/neo-adjuvant therapy is allowed. If recurrence occurs during adjuvant/neoadjuvant therapy or within ≤24 weeks after completion, adjuvant/neoadjuvant therapy is considered to be a first-line pre-systemic chemotherapy for advanced disease. (3) Early-stage immunotherapy, combined chemotherapy or combined targeted drugs are allowed (except for VEGFR inhibitors).
  4. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria
  5. ECOG performance status 0-1.
  6. An expected survival of > 12 weeks.
  7. Has adequate sufficient organ and bone marrow functions.
  8. Patients whose adverse events caused by previous treatment have recovered to <= CTCAE 1 degree; And the interval between receiving nitroso or mitomycin ≥6 weeks; Receiving other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has healed completely.
  9. Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug
  10. Patients have agreed and signed the informed consent. Willingness and able to follow the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion Criteria:

  1. It is known that it's allergic to any test drug and its excipients.
  2. Previously received anti-angiogenic therapy, such as Ramucirumab and apatinib.
  3. patients with uncontrolled large amount of exudate [chest, pericardium, abdominal cavity]
  4. Patients with partial or complete gastrointestinal obstruction.
  5. Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
  6. Patients with uncontrolled clinical symptoms or diseases of the heart.
  7. In the first 3 months of the study, patients who had significant clinical bleeding symptoms or had definite bleeding tendency; History of gastrointestinal perforation and/or fistulae within 6 months prior to medications.
  8. Long term use of aspirin, clopidogrel and other antiplatelet drugs, or warfarin and other anticoagulants;
  9. Received other therapy within 4 weeks.
  10. The patients who received systemic treatment with Chinese herbal medicine or immunomodulatory drugs
  11. According to the research's judgement, there are patients who seriously endanger the safety of patients or affect the patients who complete.(such as uncontrolled hypertension、diabetes、thyroid disease, etc)
  12. The patient has a serious or non healing wound or peptic ulcer or bone fracture;
  13. A patient with other malignancies within 3 years.
  14. patients whose adverse events (except hair loss) caused by previous treatment have not recovered to <= CTCAE 1 degree;
  15. The researchers considered unsuitable for inclusion.

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
Eksperimentel: Experimental Group
apatinib combine with chemotherapy. Apatinib: initial dose: 500mg,oral,once a day, after meal ( try to take the medicine at the same time each day) Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。
In experimental group, the drug used with apatinib and chemotherapy.
Ingen indgriben: Control Gtoup
chemotherapy Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival [PFS]
Tidsramme: 36 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective tumor response rate [ORR]
Tidsramme: 1year
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
1year
disease control rate [DCR]
Tidsramme: 1year
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1)
1year
Duration of response [DoR]
Tidsramme: 1year
Duration of response
1year
overall survival [OS]
Tidsramme: 3year
OS is defined as the length of time from random assignment to death or to last contact.
3year
Adverse Events [AEs]
Tidsramme: 1year
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
1year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Tao Zhang, Doctor, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

26. august 2021

Primær færdiggørelse (Forventet)

31. december 2022

Studieafslutning (Forventet)

3. marts 2023

Datoer for studieregistrering

Først indsendt

26. august 2021

Først indsendt, der opfyldte QC-kriterier

26. august 2021

Først opslået (Faktiske)

31. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 Mavekræft

Kliniske forsøg med Apatinib

Abonner