Treatment for operable recurrent nasopharyngeal carcinoma
Toripalimab Combined With Nimotuzumab Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma：A Single-arm, Phase II Clinical Tria
This study is testing a new combination of medications for patients with operable recurrent nasopharyngeal cancer to see if it helps them live longer without the cancer coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Radiation, triplizumab, nituzumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06912711 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a combination of toripalimab and nimotuzumab in the induction and adjuvant treatment of surgically resectable local recurrent nasopharyngeal carcinoma. It targets patients with specific tumor classifications (rT1, rT2, rT3) that are confined to certain anatomical areas and have recurred more than six months after prior radiotherapy. The primary outcome measure is the two-year progression-free survival (PFS).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with histologically confirmed recurrent nasopharyngeal carcinoma that is resectable.
Not a fit: Patients with tumors invading the internal carotid artery or those less than 0.5cm from it may 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 recurrent nasopharyngeal carcinoma.
How similar studies have performed: While this approach is novel, similar studies targeting recurrent cancers with immunotherapy have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Voluntarily participate in and sign the informed consent in person. 2. Aged 18-65 years, male or non-pregnant female. 3. Histologically and/or cytologically confirmed recurrent nasopharyngeal carcinoma (keratinized or non-keratinized carcinoma; Differentiated or undifferentiated) 4. Patients with recurrence time more than 6 months from the end of radiotherapy; 5. Recurrent nasopharyngeal carcinoma that can be resectable: rT1, rT2 (the tumor is confined to the surface of the parapharyngeal space, and the distance from the internal carotid artery is greater than that from the internal carotid artery 0.5cm), rT3 (confined to the floor wall of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage). If the tumor invades the internal carotid artery, or is less than 0.5cm away from the internal carotid artery, but the invasion scope does not exceed the external edge of the internal carotid artery, it can be advanced Internal carotid artery preconditioning (including internal carotid artery embolization or stent implantation) was followed. 6\. ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vital organs. 7\. Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L. 8\. Liver function: ALT and AST\< 2.5 times the upper limit of normal (ULN), total bilirubin \<2.0×ULN. 9\. Renal function: serum creatinine \<1.5×ULN. Exclusion Criteria: * 1\. The pathological findings were keratinized squamous cell carcinoma (WHO type I). 2\. Received systemic or local glucocorticoid therapy within 4 weeks before enrollment. 3\. Patients who have participated in other drug clinical trials within 3 months before treatment. 4\. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 5. Idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), clinical symptoms or Radiation pneumonia, active pneumonia, or other moderate to severe lung disease requiring steroid treatment 6. Have a comorbiditis that requires prolonged treatment with immunosuppressive drugs or systemic or local use of immunosuppressive doses of corticosteroids. 7\. The subject has any active autoimmune disease or history of autoimmune disease (including, but not limited to, interstitial disease) Pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, hyperthyroidism, hypothyroidism; Suffer from Patients with vitiligo or asthma that had completely resolved in childhood and did not require any intervention in adulthood were included; Need bronchus Dilators for medical intervention in asthma were not included). 8\. Positive HBV DNA copy number was detected in both HIV-positive and HBsAg positive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive) with HCV RNA positive detection. 9\. Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment. 10\. Pregnancy test positive women of childbearing age and breastfeeding women. 11. Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
Where this trial is running
Guangzhou, Guangdong
- Sun yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
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.