Endostatin and Capecitabine: Patients received radiotherapy Combined With Endostatin(37.5mg/m2, continuous intravenous infusion for 120h, D-7, D8, D22, D36) and Capecitabine( 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles)
Study summary
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Recurrence free survival (RFS) — 3 years calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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