Clinical trial · Interventional
ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy
ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy With or Without Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unacceptable toxicity (nasopharynx necrosis and massive hemorrhage)
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apatinib
- description
- 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.
- interventionNames
- Drug: Apatinib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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: 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
References
Publications (0)
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