New treatments for advanced nasopharyngeal cancer with detectable EBV DNA after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan Universtiy Shanghai Cancer Centre
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chengrun Du
• Email: duchengrun@qq.com
• Phone: +86-15001733593

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing two treatment regimens for high-risk nasopharyngeal carcinoma

  This study is testing a new combination of treatments for patients with high-risk nasopharyngeal cancer to see if it works better than the standard treatment.

  Recruiting at 2 sites Phase 3 Sun Yat-sen University · Guangzhou, Guangdong and 1 other locations · NCT06438627

• Comparing two treatments for advanced nasopharyngeal carcinoma

  This study is testing a new combination treatment for advanced nasopharyngeal cancer to see if it works better than the standard treatment.

  Recruiting Phase 3 Air Force Military Medical University, China · Xi'an, Shaanxi · NCT06026878

• Combining camrelizumab with targeted radiotherapy for advanced nasopharyngeal cancer

  This study is testing if combining a new cancer drug with targeted radiation can help people with advanced nasopharyngeal cancer live longer and possibly be cured compared to just using the drug alone.

  Recruiting Phase 3 Sun Yat-sen University · Guangzhou, Guangdong · NCT04944914

• Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies

  This trial tests whether combining ivarmacitinib with camrelizumab and fruquintinib can help patients with metastatic colorectal cancer who have progressed after multiple treatments.

  Recruiting Phase 2 Renmin Hospital of Wuhan University · Wuhan, Hubei · NCT07896096

• Interferon-gamma plus camrelizumab with chemotherapy before surgery for locally advanced esophageal squamous cell carcinoma

  This trial tests whether giving interferon-gamma with camrelizumab and chemotherapy before surgery helps patients with locally advanced esophageal squamous cell carcinoma.

  Recruiting at 2 sites Phase 2 Hefei Cancer Hospital of the Chinese Academy of Sciences · Hefei, Anhui and 1 other locations · NCT07787273

• Immune Sandwich: Induction with Nimotuzumab and Toripalimab Plus Radiotherapy vs Full-Course Immunotherapy for Advanced Nasopharyngeal Cancer

  This trial tests whether a shortened, targeted immunotherapy plan added to chemoradiation can match the full immunotherapy approach for locally advanced nasopharyngeal cancer in adults 18–70.

  Recruiting Phase 3 Sun Yat-sen University · Guangzhou, Guangdong · NCT07706985

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.