- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02874651
ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy (ADVANCE)
25 december 2021 uppdaterad av: Jun Ma, MD, Sun Yat-sen University
ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy With or Without Chemotherapy
This study will enroll patients with non-metastatic nasopharyngeal carcinoma (NPC) that have residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy.
The purpose is to evaluate the survival in these patients treated with apatinib (YN968D1), an inhibitor of vascular endothelial growth factor receptor (phase IIa) and to compare the survival in these patients treated with apatinib versus placebo (phase IIb).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study has two parts.
In the single arm phase IIa part, we will enroll 25 patients that have residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy.
All patients will receive apatinib.
The purpose is to evaluate the disease free-survival (DFS) in these patients treated with apatinib.
In the phase IIb part, patients will be randomized to apatinib or placebo in a ratio of 1:1.
The estimated sample size is 78 in phase IIb.
However, the final sample size in phase IIb will be determined based on results of the phase IIa part.
Studietyp
Interventionell
Inskrivning (Faktisk)
25
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Guangdong
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Foshan, Guangdong, Kina, 528000
- Affiliated Foshan Hospital of Sun Yat-sen University
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Guangzhou, Guangdong, Kina, 510060
- Sun Yat-sen University Cancer Center
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Guangxi
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Guilin, Guangxi, Kina, 541000
- Affiliated Hospital of Guilin Medical University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Biopsy proven nasopharyngeal carcinoma, with detectable pretreatment plasma EBV DNA
- Have detectable plasma EBV DNA at the end of (+/- 1 week) curative radiotherapy or chemoradiotherapy (radiation dose > 66Gy), determined by the central lab
- No clinical evidence of persistent loco-regional disease
- No evidence of distant metastasis, based upon skeletal scintigraphy, chest X-ray examination, and liver ultrasound or other appropriate workup (e.g., CT, MRI or positron emission tomography (PET)/CT]) within 21 days prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Anticipated survival >= 3 months
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
- Platelets > 80,000 cells/mm^3
- Hemoglobin >= 8.0 g/dl (no transfusion within the last 14 days)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x institutional ULN
- Creatinine clearance (CC) >= 50 ml/min estimated by Cockcroft-Gault formula
Exclusion Criteria:
- Patients with stage III-IV disease (American Joint Committee On Cancer/Union for International Cancer Control 7th) and no contraindication to chemotherapy that didn't receive platinum based concurrent chemotherapy during radiation
- Patients with tumor possibly invaded main vessels (e.g. encasement of the internal jugular artery/vein) at diagnosis; or tumor that, in the judgment of the investigator, likely to invade main vessels and cause life-threatening hemorrhage events during study
- History of serious hemorrhage events or grade 3 or higher hemorrhage within 4 weeks prior to registration
- Hypertension that couldn't be well controlled with single medication; unstable angina; angina diagnosed within the last 3 months; myocardial infarction within the last 6 months; cardiac arrhythmia that need long-term medication; grade 2 or higher cardiac dysfunction (NYHA)
- Proteinuria
- Coagulation dysfunction or predisposition to hemorrhage; on treatment of anticoagulation medication or vitamin K antagonist; low dose warfarin (1mg po qd) or aspirin (less than 100mg daily) were permitted as long as the international normalized ratio (INR) = < 1.5
- Thrombosis within the last 1 year, except cured vein thrombosis related to vein indwelling catheter
- Unhealed bone fracture or chronic unhealed wound
- Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
- Pregnant or lactating women
- Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during and within 6 months after study
- Current drug abuse or mentally disabled
- History of congenital or acquired immune deficiency disease or organ transplantation
- Major medical illness, which in the investigator's opinion would endanger the patients or interfere with the completion of therapy and follow up
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Apatinib
In the phase IIb part of this trial, patients in this arm will take oral apatinib until disease progression, intolerable toxicity, death or to a maximum of 2 years.
|
Patients will take oral apatinib.
The initial dose is 500 mg once daily.
28 days as one cycle.
After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance.
Dose interruption or reduction is permitted in case of adverse events per protocol.
Andra namn:
|
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Placebo-jämförare: Placebo
In the phase IIb part of this trial, patients in this arm will take oral placebo until disease progression, intolerable toxicity, death or to a maximum of 2 years.
|
Patients will take oral placebo.
The initial dose is 500 mg once daily.
28 days as one cycle.
After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance.
Dose interruption or reduction is permitted in case of adverse events per protocol.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Sjukdomsfri överlevnad
Tidsram: 3 år
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3 år
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
total överlevnad
Tidsram: 5 år
|
5 år
|
|
Antal deltagare med behandlingsrelaterade biverkningar enligt bedömning av CTCAE v4.0
Tidsram: 2 år
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2 år
|
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Changes in quality of life (QOL) as assessed by EORTC QLQ-C30
Tidsram: 2 years
|
2 years
|
|
Distance Metastasis Free Survival
Tidsram: 3 years
|
3 years
|
|
locoregional relapse free survival
Tidsram: 3 years
|
3 years
|
|
Correlation of plasma EBV DNA load with the effect of apatinib on survival
Tidsram: 3 years
|
3 years
|
|
Correlation of pretreatment serum VEGF level with the effect of apatinib on survival
Tidsram: 3 years
|
3 years
|
|
Correlation of pretreatment serum VEGFR-2 level with the effect of apatinib on survival
Tidsram: 3 years
|
3 years
|
|
Correlation of adverse event (hypertension) with the effect of apatinib on survival
Tidsram: 3 years
|
3 years
|
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Correlation of adverse event (hand-foot syndrome) with the effect of apatinib on survival
Tidsram: 3 years
|
3 years
|
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Correlation of the change from baseline in serum VEGF level at 4 weeks with the effect of apatinib on survival
Tidsram: 3 years
|
3 years
|
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Correlation of the change from baseline in serum VEGFR-2 level at 4 weeks with the effect of apatinib on survival
Tidsram: 3 years
|
3 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2016
Primärt slutförande (Faktisk)
29 november 2018
Avslutad studie (Faktisk)
27 augusti 2020
Studieregistreringsdatum
Först inskickad
1 augusti 2016
Först inskickad som uppfyllde QC-kriterierna
17 augusti 2016
Första postat (Uppskatta)
22 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 januari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 december 2021
Senast verifierad
1 december 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Virussjukdomar
- Infektioner
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Faryngeala neoplasmer
- Otorhinolaryngologiska neoplasmer
- Neoplasmer i huvud och hals
- Nasofaryngeala sjukdomar
- Faryngeala sjukdomar
- Stomatogena sjukdomar
- Otorhinolaryngologiska sjukdomar
- DNA-virusinfektioner
- Tumörvirusinfektioner
- Herpesviridae-infektioner
- Carcinom
- Nasofaryngealt karcinom
- Nasofaryngeala neoplasmer
- Epstein-Barr-virusinfektioner
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Proteinkinashämmare
- Apatinib
Andra studie-ID-nummer
- Ahead-N301
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .