Clinical trial · Interventional
Radiotherapy Combined With Endostatin and Capecitabine for NPC
Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy
NCT05514275CI-TRIAL-00060534recruitingPhase 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)
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.
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 |
|---|---|---|---|
| Endostatin and Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostatin and Capecitabine
- description
- Patients received radiotherapy Combined With Endostatin and Capecitabine
- interventionNames
- Drug: Endostatin and Capecitabine
Primary outcomes (1)
- measure
- Recurrence free survival (RFS)
- timeFrame
- 3 years
- description
- calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
Secondary outcomes (5)
- measure
- overall survival (OS)
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition). No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) \> 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL. Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN. Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent. unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT) Exclusion Criteria: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
References
Publications (0)
Data not yet available
No reference posted for this study.