NCT05514275 Radiotherapy Combined With Endostatin and Capecitabine for NPC
| NCT ID | NCT05514275 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang Cancer Hospital |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 41 participants in total. It began in 2022-08-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.
Eligibility Criteria
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)
Contact & Investigator
Ting Jin, MD
STUDY CHAIR
Department of Radiation Oncology, Zhejiang Cancer Hospital
Frequently Asked Questions
Who can join the NCT05514275 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05514275 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05514275 currently recruiting?
Yes, NCT05514275 is actively recruiting participants. Contact the research team at jinting@zjcc.org.cn for enrollment information.
Where is the NCT05514275 trial being conducted?
This trial is being conducted at Hangzhou, China, Jiaxing, China, Jinhua, China, Lishui, China and 3 additional locations.
Who is sponsoring the NCT05514275 clinical trial?
NCT05514275 is sponsored by Zhejiang Cancer Hospital. The principal investigator is Ting Jin, MD at Department of Radiation Oncology, Zhejiang Cancer Hospital. The trial plans to enroll 41 participants.