Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

Launched by CANCER HOSPITAL OF GUANGXI MEDICAL UNIVERSITY · May 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with a specific type of cancer called recurrent nasopharyngeal carcinoma, which means the cancer has come back in the area around the throat and nose after initial treatment. Researchers want to see if adding a medication called Toripalimab, which helps the immune system fight cancer, to standard chemotherapy and radiation treatment (cisplatin) is more effective than using chemotherapy and radiation alone.

To participate in this trial, patients must be between 18 and 65 years old and have a confirmed diagnosis of recurrent nasopharyngeal carcinoma. They should also be in good overall health, with specific blood test results indicating normal function of the liver and kidneys. Participants can expect to be closely monitored for how well the treatment works and what side effects, if any, they experience. It's important to know that this trial is currently recruiting participants, and those interested will need to sign a consent form to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
• • 2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
• • 3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
• • 4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
• • 5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
• • 6. With normal renal function test ( creatinine clearance ≥60 ml/min)
• • 7. sign an "informed consent form
• • 8. Male and no pregnant female
• Exclusion Criteria:
• • 1. Age older than 65, or younger than 18 years old
• • 2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
• • 3. Patients with positive HCV antibody.
• • 4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
• • 5. History of interstitial lung disease
• • 6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
• • 7. Receive or will receive live vaccine within 30 days prior to signing the informed consent.
• • 8. Women of child-bearing potential who are pregnant or breastfeeding.
• • 9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
• • 10. Hypersensitivity to macromolecular protein, or to any component of triplezumab.
• • 11. HIV positive.
• • 12. Severe, uncontrolled medical conditions and infections.
• • 13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.