Clinical trial · Interventional
Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma
NCT03180476CI-TRIAL-00065666completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug safety.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apatinib
- description
- apatinib,500mg,qd,28 day/cycle until the emergence of PD, death, intolerable toxicity
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 12 months
- description
- The first day of treatment to the date that disease progression is reported
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- up to 24 months
- description
- the first day of treatment to death or last survival confirm date.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients aged ranging from 18 to 75 years old. * Naive or recurrent Nasopharyngeal Carcinoma with metastasis after chemotherapy or radiotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2. * Adequate hematologic (neutrophil count\>=1.5×109/L, hemoglobin\>=80g/L, platelets\>=80×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT) =\<upper normal limit(UNL) x2, bilirubin level =\< UNL x 1.5). * Adequate renal function (creatinine clearance ≥ 60 mL/min). * Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up. Exclusion Criteria: * Previously, patients did receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib. * Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction). * Bleeding tendency or coagulation disorders. * with brain metastases. * Uncontrolled hypertension (systolic pressure\>150 mmHg , or diastolic pressure\> 90 mmHg). * Urine protein≥++, or urine protein in 24 hours≥1.0g * Severe uncured wounds, ulcers or fracture. * Pregnant or breast-feeding. * Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents). * Patients have these symptoms, such as neurological diseases, mental illness, serious infection. * The researcher believe that the Patient is not suitable to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.