New treatments for advanced nasopharyngeal cancer with detectable EBV DNA after chemotherapy
A Multicenter, Randomized Controlled Phase III Trial of Induction Plus Concurrent Chemoradiotherapy Plus Camrelizumab or Nimotuzumab Versus Induction Plus Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
This study is testing if adding two new treatments, camrelizumab or nimotuzumab, to standard chemotherapy can help people with advanced nasopharyngeal cancer who still have detectable EBV DNA after their first round of treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 459 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, camrelizumab, nimotuzumab, carrilizumab, nituzumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05772208 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized phase 3 trial aims to evaluate the effectiveness of adding camrelizumab or nimotuzumab to standard neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma. The study focuses on patients whose EBV DNA remains detectable after one cycle of chemotherapy, indicating a poorer prognosis. Participants will be randomly assigned to receive either the combination of camrelizumab or nimotuzumab with standard treatment, or standard treatment alone. The primary goal is to determine if these additions improve treatment outcomes for this specific patient group.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with newly diagnosed non-keratinizing nasopharyngeal carcinoma and detectable EBV DNA after one cycle of neoadjuvant chemotherapy.
Not a fit: Patients with keratinizing squamous cell carcinoma or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with advanced nasopharyngeal carcinoma who have detectable EBV DNA after initial chemotherapy.
How similar studies have performed: While there have been studies exploring treatments for nasopharyngeal carcinoma, the specific combination of therapies in this trial is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+. 2. Age 18-70 years. 3. Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer\[AJCC\] edition). 4. Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant. 5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L. 7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.0×ULN. 8. Renal function: serum creatinine \<1×ULN. 9. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: 1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I) 2. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. 3. Receiving radiotherapy or chemotherapy or targeted therapy previously 4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 5. Patients with significantly lower heart, liver, lung, kidney and bone marrow function. 6. Severe, uncontrolled medical conditions and infections. 7. At the same time using other test drugs or in other clinical trials. 8. Refusal or inability to sign informed consent to participate in the trial. 9. Emotional disturbance or mental
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan Universtiy Shanghai Cancer Centre — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Chengrun Du
- Email: duchengrun@qq.com
- Phone: +86-15001733593
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.