- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03654612
Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies (Y-HR2017-025)
A Single Arm,Open Clinical Study of Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Liu Ping, doctor
- Telefonnummer: 13975157508
- E-post: CYRIL0820@sina.com
Studer Kontakt Backup
- Navn: Liu Bin, doctor
- Telefonnummer: 13973127325
- E-post: Binglang3351@qq.com
Studiesteder
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Hunan
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Changsha, Hunan, Kina, 410011
- Rekruttering
- The second xiangya hospital
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Ta kontakt med:
- ping liu
- Telefonnummer: (+86)13975157508
- E-post: cyril0820@sina.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years old, male or female;
- Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);
- Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;
- According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;
- ECOG PS: 0-1 points;
Baseline blood and biochemical indicators meet the following criteria:
Hemoglobin ≥ 80g/L, Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥ 90×109/L, ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastases), Serum total bilirubin ≤ 1.5 times the normal upper limit, Serum creatinine ≤ 1.5 times the normal upper limit, Serum albumin ≥ 30g / L;
- The expected survival period is ≥3 months;
- Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.
- Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.
Exclusion Criteria:
- A person who has been confirmed to be allergic to apatinib and/or its excipients;
- Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male > 450 ms, female > 470 ms) and grade I cardiac insufficiency; urine protein positive patients;
- Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
- Patients who have used apatinib or tigeo in the first line
- abnormal blood coagulation (INR>1.5, APTT>1.5 ULN), with bleeding tendency;
- Patients with central nervous system metastases;
- Pregnant or lactating women;
- Patients with other malignancies within 5 years;
- Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
- Patients who have participated in other drug clinical trials within 4 weeks;
- Have received VEGFR inhibitors such as sorafenib and sunitinib;
- According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study;
- The investigator believes that it is not suitable for inclusion.
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: Apatinib+S-1
Patients with recurrent/metastatic head and neck malignancies received apatinib plus S-1 as second-line therapy.
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Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
PFS
Tidsramme: 40 months
|
Progression free survival
|
40 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
OS
Tidsramme: 40 months
|
Overall survival
|
40 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Andre studie-ID-numre
- ChinaIMF-LP02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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