- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03030937
Clinical Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in AGC or EGJA
A Randomized, Parallel Control, Exploratory Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in Subjects With Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Jianwei Yang
- Telefonnummer: 008613805097959
- E-post: swzcq62@163.com
Studera Kontakt Backup
- Namn: Sha Huang
- Telefonnummer: 008613763820570
- E-post: huangsha0210@163.com
Studieorter
-
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Fujian
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Fuzhou, Fujian, Kina, 350000
- Jianwei Yang
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age:18~70years;
- Subjects with Histologically or cytologically confirmed advanced gastric cancer or adenocarcinoma of esophagogastric junction ;
- Subjects must have received no more than one lines treatment before participating,and have received no irinotecan or antiangiogenic(including apatinib)treatment previously; Note:(1) Time of first-line treatment for subjects with advanced tumour must more than 1 cycles;(2) Adjuvant / neoadjuvant therapy was allowed; adjuvant / neoadjuvant therapy will be considered as a first-line treatment if disease recurrence during treatment or after less than 24 weeks.
- subjects with at least one measurable lesion as defined by RECIST (version 1.1);Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Survival expectation≥ 3 months;
- The interval of subjects had received cytotoxic drugs, radiotherapy or surgery must more than 4 weeks(besides nitroso or mitomycin must more than 6 weeks), and the wound has healed before participating;
- No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on );
Adequate organ functions defined as indicated below: (1)Adequate bone marrow function, defined as: (no blood transfusion within 14 days)
- Hemoglobin (Hb)≥80g/L,
- White blood count (WBC)≥3.5×109/L
- Absolute neutrophil count (ANC)≥1.5×109/L,
- Platelet count (PLT)≥75×109/L; (2)Adequate liver function, defined as:
- Bilirubin ≤1.5×the upper limit of normal (ULN)
- Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) ≤3.0×(ULN), Glutamyl transpeptidase(GGT)≤2.5×(ULN), (When liver metastases, ALT or AST and GPT <5.0×(ULN)).
- serum creatinine ≤1.0×(ULN), or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula)
- Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 8 weeks after study drug discontinuation. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above (i.e.not of childbearing potential or practicing highly effective contraception throughout the study period and for 8 weeks after study drug discontinuation).
- Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol
Exclusion Criteria:
- Females are lactating or pregnant at Screening or Baseline
- Subjects with other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix)
- Subjects with symptomatic brain metastases;
- Subjects with uncontrolled blood pressure with medication (140/90 mmHg),
- Subjects with coronary heart disease (CHD) above grade I, arrhythmia (including Prolongation of QTc interval : Male subjects > 450 ms, Females> 470 ms) or cardiac dysfunction;.
- Subjects with gastrointestinal bleeding tendency,including the following: current of local active ulcerative lesions with fstool OB (+ +); history of melena or hematemesis within past 2 months ; current of fstool OB (+) with gastric primary tumor without surgical , investigator considerd ulcerative stomach cancer is associated with risks of gastrointestinal bleeding.
- Subjects with bleeding tendency ,defined as abnormal coagulation (INR>1.5×(ULN),APTT>1.5 ×(ULN));
- Subjects with previous history of cardiovascular and cerebrovascular diseases ,those receiving thrombolytics or anticoagulants were excluded
- Subjects with urine protein positive (defined as urine protein detection 2+ or above, or urine protein ≥ 1 g/24 hours );
- Subjects with a variety of factors that affect oral medications (such as inability to swallow, persistent nausea and vomiting, chronic diarrhea and intestinal obstruction, and so on.);
- Subject with any other condition that in the opinion of the investigator would preclude his/her participation in a clinical study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Irinotecan plus apatinib
Irinotecan:160mg/m2, ivgtt,given on the eighth day; Apatinib:initial dose:250mg,oral,once a day, after meal ( try to take the medicine at the same time of the dauntoy ). Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities. |
Apatinib, en ny målinriktad hämmare av VEGF-receptor 2 (VEGFR2).
Irinotecan was used as second line treatment with AGC.
|
Aktiv komparator: Irinotecan
Irinotecan:180mg/m2, ivgtt,given on the eighth day.
Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.
|
Irinotecan was used as second line treatment with AGC.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression-Free Survival (PFS)
Tidsram: 18 months
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18 months
|
|
Adverse Event(AE)
Tidsram: 18 months
|
NCI CTC 4.03
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18 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Objective Response Rate (ORR)
Tidsram: 18 months
|
18 months
|
|
Disease Control Rate (DCR)
Tidsram: 18 months
|
18 months
|
|
Overall Survival(OS)
Tidsram: 18 months
|
18 months
|
|
Quality of Life (QoL)
Tidsram: 18 months
|
Use the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30].
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18 months
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Carcinom
- Neoplasmer, körtel och epitel
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Magsjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Neoplasmer i magen
- Adenocarcinom
- Esofagusneoplasmer
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Topoisomerasinhibitorer
- Proteinkinashämmare
- Topoisomeras I-hämmare
- Irinotekan
- Apatinib
Andra studie-ID-nummer
- Arise-FJ-G201
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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