- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03662035
Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer (ASPC)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
- To observe the curative efficacy of apatinib and S-1 on patients by analyzing the data of overall survival (OS), complete remission (CR) or partial remission (PR), the rate of progression free survival (PFS), levels of CA19-9 and VEGFR in serum [Time Frame: Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year].
- To observe any adverse events, including abnormal clinical symptoms and vital signs, abnormal laboratory examinations, and to record the clinical features, severity, occurrence time, duration, management and prognosis of all subjects during the clinical study, and to determine the correlation between these adverse events and the experimental drugs. . The safety of drugs used in advanced pancreatic cancer was evaluated by CTCAE v4.0
Studietype
Registrering (Forventet)
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria:
- 18-70 years old;
- ECOG score: 0-2;
- Have confirmed metastatic or locally advanced unresectable pancreatic cancer;
- At least one measurable lesion according to the RECIST1.1 standard;
- First-line chemotherapy drugs do not include S-1 or fluorouracil drugs;
Main organ functions meet the following standards:
Baseline blood routine (the inspection standard should meet the requirements of no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulant correction) :
- Hemoglobin>80g/L
- The absolute neutrophil count (ANC) 1.5 x 109 / L;
- Blood platelet (PLT)> 90 x 109 / L;
Baseline biochemical test shall meet the following standards:
- T BIL < 1.5*ULN.
- A LT and AST<2.5*ULN, and in patients with liver metastasis < 5*ULN;
- Cr≤1.5*ULN.
- Albumin is greater than or equal to 30g/L;
- Women of child-bearing age must already have access to reliable contraception. Pregnancy tests (serum or urine) were performed within 7 days prior to enrollment and the results were negative, and a reliable method of contraception was preferred 8 weeks after the trial period and the last drug administration;
- Subjects will voluntarily join the study and sign the informed consent.
Exclusion criteria:
- Clearly allergic to apatinib, S-1 or their excipients;
- There are various factors affecting oral drugs (including dysphagia, chronic diarrhea, intestinal obstruction, etc.);
Serious heart diseases in the last six months, including :
- angina;
- myocardial infarction;
- heart failure;
- interphase of QTc >450ms;
- any other heart diseases that were judged as unsuitable for the study;
- Combined with uncontrollable hypertension after drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);
- Complicated with other serious medical diseases, including cerebrovascular disease, uncontrolled infection, active peptic ulcer, intestinal obstruction, etc.;
- Metastasis of tumor central nervous system;
- Women during pregnancy and lactation;
- The patient has been diagnosed with other tumors in the past five years, except for the following situations: B. Cured basal cell carcinoma of the skin and cured orthotopic carcinoma of the cervix;
- The time from the last chemotherapy is shorter than 4 weeks or 5 half-life (the time taken is older), and the time from the last radiotherapy is shorter than 4 weeks;
- Use the experimental drug within 28 days before enrollment;
- Patients with grade 2 or above toxicity caused by the use of anti-tumor drugs before enrollment;
- Have mental disorders or a history of substance abuse;
- Other circumstances that the investigator deems inappropriate to participate in the study;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: single-arm
Apatinib and S-1 Patients will be offered with Apatinib (500mg/d) and S-1 (60mg/d for BSA<1.25m2,
80mg/d for 1.25<BSA<1.5m2,
and 100mg for BSA >1.5m2) until their disease have progressed.
|
Apatinib Patients with advanced pancreatic cancer after failure of first-line chemotherapy will receive Apatinib (500mg/d, orally) 30 minutes after meal with warm water.Take 21 days as a cycle, patients will receive this treatment until they have got disease progressed. Dose adjustment: with 3/4 level of adverse reactions, the dose should be lowered to 250 mg/d. S-1 Patients will receive S-1 (60mg/d for BSA<1.25m2,
80mg/d for 1.25 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Progression Free Survival
Tidsramme: one year.
|
Progression-free survival is defined as the time from registration to the earlier of death or disease progression.
|
one year.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall Survival
Tidsramme: one year.
|
OS refers to the date of registration to the date of death for any cause.
|
one year.
|
Duration of response
Tidsramme: one year.
|
DOR refers to the time from the time the measurement first conforms to the CR or PR criteria (whichever is first measured) to the time the first true record of disease recurrence or progression (using the minimum measurements recorded in the trial as a reference for disease progression).
|
one year.
|
Objective response rate
Tidsramme: one year.
|
ORR refers to the proportion of patients whose tumors have shrunk to a certain extent for a certain period of time, including CR and PR cases
|
one year.
|
Disease Control Rate
Tidsramme: one year.
|
DCR refers to the percentage of patients with confirmed complete remission, partial remission, and disease stabilization (> 8 weeks) who can evaluate efficacy
|
one year.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Sykdommer i det endokrine systemet
- Neoplasmer i fordøyelsessystemet
- Neoplasmer i endokrine kjertel
- Pankreassykdommer
- Neoplasmer i bukspyttkjertelen
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Proteinkinasehemmere
- Apatinib
Andre studie-ID-numre
- ChangzhouNo2
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Avansert kreft i bukspyttkjertelen
-
Providence Health & ServicesTilgjengeligKRAS G12V Mutant Advanced Epithelial Cancers
-
Shanghai Pudong HospitalUTC Therapeutics Inc.TilbaketrukketMesothelin-positive Advanced Refractory Solid TumorsKina
-
Novartis PharmaceuticalsFullførtcMET Dysegulation Advanced Solid TumorsØsterrike, Danmark, Sverige, Storbritannia, Spania, Tyskland, Nederland, Forente stater
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRekrutteringKRAS G12C Mutant Advanced Solid TumorsKina
-
AZ-VUBAstraZeneca; Kom Op Tegen KankerRekrutteringAdvanced Cancers Harboring Mutations in HRGBelgia
-
AmgenAktiv, ikke rekrutterendeKRAS p.G12C Mutant Advanced Solid TumorsForente stater, Frankrike, Canada, Spania, Belgia, Korea, Republikken, Østerrike, Australia, Ungarn, Hellas, Tyskland, Japan, Romania, Sveits, Brasil, Portugal
-
Tianjin Medical University Cancer Institute and...Har ikke rekruttert ennåPDAC - Pancreatic Ductal Adenocarcinoma
-
Sun Yat-sen UniversityRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaKina
-
Agenus Inc.FullførtAvansert solid kreft | Advanced Solid Cancers Refractory to PD-1Forente stater
-
Yongchang ZhangRekrutteringHER2 Insertion Mutation Positive Advanced NSCLCKina
Kliniske studier på Apatinib
-
Elevar TherapeuticsFullførtAdenoid cystisk karsinomForente stater, Korea, Republikken
-
Lei LiFullførtKjemoterapi | Tilbakevendende livmorhalskreft | Apatinib | Målrettet terapi | Vedvarende avansert livmorhalskreft | Vaskulær endotelial vekstfaktor 2-hemmerKina
-
Peking University Cancer Hospital & InstituteRekruttering
-
Huazhong University of Science and TechnologyUkjent
-
The First Affiliated Hospital of Zhengzhou UniversityRekrutteringEsophageal Cancer av AJCC V8 StageKina
-
Peking UniversityJiangsu HengRui Medicine Co., Ltd.Rekruttering
-
The First Affiliated Hospital of Zhengzhou UniversityRekruttering
-
Peking Union Medical College HospitalFullførtKreft i skjoldbruskkjertelenKina
-
Peking Union Medical College HospitalFullførtKolangiokarsinom | Hepatobiliær neoplasma | Galdeveiskreft | BiomarkørKina
-
Sun Yat-sen UniversityHar ikke rekruttert ennåNSCLC | Ikke-småcellet lungekreftKina