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TerminatedNCT02874651ADVANCEUpdated Jan 11, 2022

ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy

A Phase 2 interventional study of Apatinib and Placebo in Nasopharyngeal Neoplasms, sponsored by Sun Yat-sen University. Terminated at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

Why this study was terminated
Unacceptable toxicity (nasopharynx necrosis and massive hemorrhage)
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Nasopharyngeal Neoplasms

Keywords

  • Nasopharyngeal Carcinoma
  • EB Virus
  • DNA
  • vascular endothecial growth factor receptor inhibitor
  • Apatinib
03

In context

Nasopharyngeal Neoplasms

242 studies on the registry are indexed under Nasopharyngeal Neoplasms; 47 are open to participants now.

This study's enrollment of 25 is below the median of 59 across 199 interventional studies indexed under Nasopharyngeal Neoplasms.

Browse Nasopharyngeal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Biopsy proven nasopharyngeal carcinoma, with detectable pretreatment plasma EBV DNA
  2. Have detectable plasma EBV DNA at the end of (+/- 1 week) curative radiotherapy or chemoradiotherapy (radiation dose > 66Gy), determined by the central lab
  3. No clinical evidence of persistent loco-regional disease
  4. 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
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  6. Anticipated survival >= 3 months
  7. Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3
  8. Platelets > 80,000 cells/mm\^3
  9. Hemoglobin >= 8.0 g/dl (no transfusion within the last 14 days)
  10. Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
  11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x institutional ULN
  12. Creatinine clearance (CC) >= 50 ml/min estimated by Cockcroft-Gault formula

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. 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
  3. History of serious hemorrhage events or grade 3 or higher hemorrhage within 4 weeks prior to registration
  4. 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)
  5. Proteinuria
  6. 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
  7. Thrombosis within the last 1 year, except cured vein thrombosis related to vein indwelling catheter
  8. Unhealed bone fracture or chronic unhealed wound
  9. Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
  10. Pregnant or lactating women
  11. 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
  12. Current drug abuse or mentally disabled
  13. History of congenital or acquired immune deficiency disease or organ transplantation
  14. Major medical illness, which in the investigator's opinion would endanger the patients or interfere with the completion of therapy and follow up
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Apatinib

  • Placebo comparator
    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.

    Drug: Placebo

Interventions

  • 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.

    Also known as: YN968D1

  • DrugPlacebo

    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.

    Also known as: Placebo tablet

06

What researchers measure

Primary outcomes

  1. Disease-free survival

    Time frame: 3 years

Secondary outcomes

  1. overall survival

    Time frame: 5 years

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 2 years

  3. Changes in quality of life (QOL) as assessed by EORTC QLQ-C30

    Time frame: 2 years

  4. Distance Metastasis Free Survival

    Time frame: 3 years

  5. locoregional relapse free survival

    Time frame: 3 years

  6. Correlation of plasma EBV DNA load with the effect of apatinib on survival

    Time frame: 3 years

  7. Correlation of pretreatment serum VEGF level with the effect of apatinib on survival

    Time frame: 3 years

  8. Correlation of pretreatment serum VEGFR-2 level with the effect of apatinib on survival

    Time frame: 3 years

  9. Correlation of adverse event (hypertension) with the effect of apatinib on survival

    Time frame: 3 years

  10. Correlation of adverse event (hand-foot syndrome) with the effect of apatinib on survival

    Time frame: 3 years

  11. Correlation of the change from baseline in serum VEGF level at 4 weeks with the effect of apatinib on survival

    Time frame: 3 years

  12. Correlation of the change from baseline in serum VEGFR-2 level at 4 weeks with the effect of apatinib on survival

    Time frame: 3 years

07

Study locations

3 sites
  • Affiliated Foshan Hospital of Sun Yat-sen University
    Foshan, Guangdong 528000, China
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
  • Affiliated Hospital of Guilin Medical University
    Guilin, Guangxi 541000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02874651
Collaborators
First People's Hospital of Foshan, Guilin Medical University, China
Responsible party
Jun Ma, MD (Prof., Sun Yat-sen University) — Principal investigator
First posted
Aug 22, 2016
Start date
Oct 2016
Primary completion
Nov 29, 2018
Completion
Aug 27, 2020
Last update
Jan 11, 2022

Study contacts

Jun Ma, M.D.
study chair · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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