Combining radiotherapy with endostatin and capecitabine for nasopharyngeal carcinoma
Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy
This study is testing if combining radiotherapy with two medications, endostatin and capecitabine, can help people with nasopharyngeal cancer who didn't respond to initial chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Hangzhou, Zhejiang and 6 other locations) |
| Trial ID | NCT05514275 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the effectiveness of radiotherapy combined with recombinant human endostatin and capecitabine in patients with nasopharyngeal carcinoma (NPC) who are resistant to induction chemotherapy. The study involves 41 patients with locally advanced NPC, focusing on their recurrence-free survival as the primary endpoint. Secondary objectives include overall survival, distant metastasis-free survival, local-regional free survival, and the assessment of adverse events and quality of life. The trial is designed to provide insights into the safety and efficacy of this combined treatment approach.
Who should consider this trial
Good fit: Ideal candidates are patients with newly confirmed non-keratinizing nasopharyngeal carcinoma who have not responded to neoadjuvant chemotherapy.
Not a fit: Patients with keratinizing squamous cell carcinoma or those with distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with resistant nasopharyngeal carcinoma.
How similar studies have performed: While there have been studies on radiotherapy and chemotherapy combinations, the specific use of endostatin in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hangzhou, Zhejiang and 6 other locations
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
- the First Hospital of Jiaxing — Jiaxing, Zhejiang, China (Recruiting)
- Jinhua Central Hospital — Jinhua, Zhejiang, China (Recruiting)
- The Central Hospital of Lishui City — Lishui, Zhejiang, China (Recruiting)
- Ningbo First Hospital — Ningbo, Zhejiang, China (Recruiting)
- Ningbo Medical Center Lihuili Eastern Hospital — Ningbo, Zhejiang, China (Recruiting)
- People's Hospital of Quzhou — Quzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Ting Jin, MD
- Email: jinting@zjcc.org.cn
- Phone: +86-571-88128202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.