Combining PD-1 inhibitors and anti-EGFR therapy with radiotherapy for resistant nasopharyngeal carcinoma
Radiotherapy Combined With PD-1 Inhibitor and Anti-EGFR Monoclonal Antibody for Locally Advanced Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy: A Prospective Phase II Study
This study is testing a new treatment that combines PD-1 inhibitors and anti-EGFR therapy with radiotherapy to see if it helps people with advanced nasopharyngeal cancer who didn't respond well to earlier chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06156878 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining PD-1 inhibitors and anti-EGFR therapy with radiotherapy in patients with locally advanced nasopharyngeal carcinoma (NPC) who have shown resistance to induction chemotherapy. The study aims to explore a treatment approach that minimizes toxic side effects while improving patient outcomes. Participants will be evaluated based on their response to prior chemotherapy and specific eligibility criteria, including the presence of EGFR positivity. The trial is designed to assess whether this combination therapy can enhance treatment efficacy in a challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed locally advanced NPC who have shown less than 50% response to induction chemotherapy and are EGFR positive.
Not a fit: Patients with previous anti-tumor treatments, severe organ dysfunction, or those with uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less toxic treatment option for patients with resistant nasopharyngeal carcinoma.
How similar studies have performed: Other studies have shown promising results with similar combinations of PD-1 inhibitors and anti-EGFR therapies in head and neck cancers, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Histologically confirmed locally advanced NPC; IHC EGFR positive; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Imaging assessment of MR after induction chemotherapy revealed the responses to induction chemotherapy are less than 50% Partial Response(PR) or EBVDNA copy number decreased by less than 50%; No prior anti-tumor treatment; Normal complete blood count; Normal hepatic function; Normal renal function (creatinine ≤ 1.5 times the upper limit of normal). - Exclusion Criteria: Previous radiotherapy; A history of any other type of malignancy; Pregnancy or lactation; Allergy to anti-EGFR monoclonal antibody; IHC EGFR negative; Allergy to PD-1 inhibitor; Obvious disfunction of liver, renal, cardiac or lung function; Un controlled infection; Systemic metastasis or distant metastasis; Patients with severe gastrointestinal diseases; Patients with mental disorders affecting patient participation in trial judgement; Cannot take contrast-MRI imaging. -
Where this trial is running
Shanghai, Shanghai
- Eye & ENT Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Xiaoshen Wang, MD, Ph.D
- Email: xiaoshen.wang@fdeent.org
- Phone: 18917785187
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.