Clinical trial · Interventional
Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis
Efficacy and Safety Evaluation of Tegio Consolidation Therapy in the Treatment of Nasopharyngeal Carcinoma With High Risk of Metastasis: a Phase II Study
NCT03904225CI-TRIAL-00052407unknownPhase 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)
oral administration of Tegio capsules for 12 months for NPC patients with high risk of metastasis (AJCC stage T3-4N2M0 or T1-4N3M0) was tested trying to reduce distant metastasis，safety was also evaluated.
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 Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tegafur-Gimeracil-Oteracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- tegio
- description
- Tegio 60mg bid d1-28 q6wks was administered until disease progression, unacceptable toxicity,or over 12monthes within 3monthes after curative chemoradiation
- interventionNames
- Drug: Tegafur-Gimeracil-Oteracil
- type
- NO_INTERVENTION
- label
- control
- description
- patients was oberved
Primary outcomes (1)
- measure
- distant metastsis-free survival (DMFS)
- timeFrame
- From date of randomization until the date of first documented distant disease failure, assessed up to 36 months
- description
- distant metastsis-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-70 ys 2. Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 -2 3. Tumor staged as 8th American Joint Committee on Cance (AJCC) T3-4N2M0 or T1-4N3M0 with histologically confirmed 4. Within 12weeks after completion of the curative radiotherapy treatment 5. disease was controlled after radiotherapy 6. with adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \< 2.5×ULN) and renal function (creatinine clearance \> 50 ml/min) 7. Patients must be informed and written informed consent was finished. Exclusion Criteria: 1. allergic to Tegio. 2. Illness may interfere with oral medication, including dysphagia, chronic diarrhea, or ileus 3. Prior malignancy except treated basal cell or in situ cervical cancer. 4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). 5. severe comorbidities may bring unacceptable risk or affect the compliance of the trial, including but not limited to unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
References
Publications (0)
Data not yet available
No reference posted for this study.