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Exploratory Clinical Study of Apatinib and PD-1 in Treating Advanced Gastric Cancer

15. mai 2019 oppdatert av: Henan Cancer Hospital

Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer

The Purpose of This Study is to Evaluate the Efficacy and Safety of Apafitini Combined With PD1 in Patients With Advanced Gastric Cancer After Second-line Treatment Failure, Thus Providing More Options for Patients With Advanced Gastric Cancer.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Detaljert beskrivelse

Patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.

Studietype

Intervensjonell

Registrering (Forventet)

35

Fase

  • Fase 2

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
  2. To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed advanced Gastric Cancer.
  3. Failure of the second-line standard treatment regimen (disease progression), >14 days from the last chemotherapy, chemotherapy regimen including fluorouracil (5-FU / capecitabine / teggio), oxaliplatin and irinotecan; Acceptable or not received bevacizumab/cetuximab/regofenib treatment.
  4. Aged 18-70 years old, both genders.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  6. Life expectancy of at least 3 months.
  7. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.If the lesion receiving local therapy (radiotherapy, radiofrequency, interventional therapy, etc.) is the only lesion, definite imaging progress is required.
  8. the main organ functions of the patient shall meet the following standards within 7 days before treatment:Blood routine examination standard (without blood transfusion within 7 days before enrollment)Hemoglobin ≥ 70 g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ PLT)≥80×109/L;Biochemical examination shall meet the following standards:serum total bilirubin (TBIL)≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal(ULN);Serum creatinine (Cr)≤1.5ULN or creatinine removal rate (CCr)≥60ml/min;
  9. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period。

Exclusion Criteria:

  1. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg;
  2. Diabetes blood sugar control is poor;
  3. Acute phase of cerebral infarction, or recovery period <2 months;
  4. Has a variety of factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction);
  5. Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterion;
  6. Coagulation abnormalities (INR>1.5×ULN,APTT>1.5×ULN),with bleeding tendency;
  7. Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation > 1.0 g;
  8. Pregnant or lactating women;
  9. Within 2 weeks after treatment with cytotoxic drugs and radiotherapy;Has taken two or more oral targeted drugs;
  10. Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years;
  11. The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
  12. Patients with severe liver and kidney dysfunction (grade 4) should be excluded;
  13. Those who are allergic to any component of apafitini mesylate should be excluded;
  14. Mental disorders history, or psychotropic drug abuse history;
  15. Previous use of regorafenib is not an exclusion criterion;
  16. According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study;
  17. Surgery was performed within 4 weeks prior to the start of treatment, or patients with major trauma or fractures. Or there is an unhealed wound before treatment;
  18. Patients with severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, or grade III or above (CCS standard) angina, or a history of myocardial infarction within 6 months prior to treatment, or an arrhythmia requiring medication;
  19. The patient has brain metastasis, meningeal metastasis;
  20. Active HBV infection and rejection of formal antiviral therapy;
  21. Active tuberculosis;
  22. Participants who have participated in any drug or medical device clinical trial within 1 month prior to the trial.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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: apatinib and PD-1
Every patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effect
  1. Apatinib starting dose of 500mg, qd, oral, taken half an hour after a meal
  2. PD-1 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Overall survival rate
Tidsramme: up to 2 year
up to 2 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective response rate
Tidsramme: up to 2 year

Defined as the proportion of patients with a documented complete response, and partial response (CR

+ PR

up to 2 year
Disease control rate
Tidsramme: up to 2 year
The time from the start of randomization to the first tumor recurrence/metastasis or the death of the subject for any reason
up to 2 year
Total overlevelse
Tidsramme: opptil 2 år
Fra dato for randomisering til dato for død uansett årsak
opptil 2 år

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. juni 2019

Primær fullføring (Forventet)

1. juni 2021

Studiet fullført (Forventet)

1. juni 2021

Datoer for studieregistrering

Først innsendt

15. mai 2019

Først innsendt som oppfylte QC-kriteriene

15. mai 2019

Først lagt ut (Faktiske)

17. mai 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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 magekreft

Kliniske studier på Apatinib and PD1

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