Combining Camrelizumab and chemotherapy with endoscopic surgery for recurrent nasopharyngeal carcinoma
A Prospective, Single-arm, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma
This study is testing if combining a new drug called Camrelizumab with chemotherapy and surgery can help people whose nasopharyngeal cancer has come back after treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | radiation, prednisone, Camrelizumab, chemotherapy |
| Locations | 7 sites (Fuzhou, Fujian and 6 other locations) |
| Trial ID | NCT05011227 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Camrelizumab, a monoclonal antibody, in combination with chemotherapy and endoscopic surgery for patients with recurrent nasopharyngeal carcinoma. The study aims to assess the safety and efficacy of this treatment approach in patients whose cancer has returned after initial treatment. Participants will undergo a thorough evaluation to ensure they meet specific criteria, including the ability to surgically remove the tumor. The trial will monitor patient outcomes to determine the potential benefits of this combined treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed recurrent nasopharyngeal carcinoma that can be surgically removed.
Not a fit: Patients with distant metastasis or those who have received prior radiation therapy in the treatment area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with recurrent nasopharyngeal carcinoma.
How similar studies have performed: While there have been studies exploring similar combinations of immunotherapy and surgery, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed recurrent nasopharyngeal carcinoma * American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent T4 which can be surgically removed * Age ≥18 years old * Informed consent signed * With or without lymph node metastasis, which can be surgically removed * No massive hemorrhage risk recently * No distant metastasis * ≥6 months from initial radiotherapy to recurrence * Radical radiation only once * Sufficient organ function * Eastern Cooperative Oncology Group score 0-2 Exclusion Criteria: * With a history of allergic to platinum drugs and similar compounds * Evidence of distant metastasis or radiation encephalopathy or leptomeningeal disease (LMD) * Have received radioactive seed implantation in the treatment area * Suffer from uncontrolled disease which could interfere with treatment * Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.) * The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on * The patients have autoimmune diseases * The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration * Severe allergic reaction to other monoclonal antibodies * Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment * Live vaccines have been inoculated within 4 weeks before the first administration or during the study period * The patient has any situation that may hinder study compliance or the safety during the study period * Existence of serious neurological or psychiatric diseases, such as dementia and seizures * Uncontrolled active infection * Pregnant or breastfeeding women * Those who have no personal freedom and independent capacity for civil conduct * There are other situations that are not suitable for entry into the study
Where this trial is running
Fuzhou, Fujian and 6 other locations
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
- Fujian Provincial Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
- Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Not_yet_recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
- Eye& ENT Hospital, Fudan University — Shanghai, Shanghai, China (Recruiting)
- Shanghai Zhongshan Hospital,Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Hongmeng Yu, MD,PHD — Eye&ENT Hospital,Fudan University
- Study coordinator: Xiaole Song, MD
- Email: jxfxsxl@163.com
- Phone: 15821388769
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.