iENE-negative HPV-positive (p16-positive) oropharyngeal squamous cell carcinoma (confirmed as HPV-associated squamous cell carcinoma by oropharyngeal biopsy pathology, with p16 positivity by immunohistochemistry and positive expression of high-risk HPV subtypes among multiple HPV subtypes). The staging follows the AJCC/UICC 9th edition: T1-3N0-2M0, excluding patients with radiologically confirmed
Conditions
Interventions
Definitive Radiotherapy Group:Definitive Radiotherapy
Dose-Reduced Radiotherapy Group:Dose-Reduced Radiotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Treatment-naïve patients with HPV-positive oropharyngeal cancer (AJCC/UICC 9th edition staging: T1-3N0-2M0, excluding patients with imaging-assessed nodal iENE positivity); 2. Confirmed pathological diagnosis of HPV-associated squamous cell carcinoma by oropharyngeal biopsy, positive for p16 by immunohistochemical staining, and positive for high-risk HPV expression in multiple HPV subtypes; 3. Age: 18-75 years; 4. ECOG performance status 0-1; 5. Pre-treatment absolute neutrophil count >=1.5 ×10^9/L, hemoglobin >=90 g/L, platelet count >=100×10^9/L; total bilirubin <=1.5 × upper limit of normal (ULN), ALT <=1.5 × ULN, AST <=1.5 × ULN, ALP <=2.5 × ULN; creatinine <=1.5 × ULN; 6. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <=1.5 × ULN (patients on stable-dose anticoagulant therapy such as low-molecular-weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants may be screened); 7. Myocardial enzyme profile within normal limits; 8. No prior radiotherapy, chemotherapy, immunotherapy, biological targeted therapy or other anti-tumor treatments for the tumor lesion; 9. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and agree to use a reliable contraceptive method during the trial; male subjects must use a reliable contraceptive method from the start of treatment until 120 days after the last dose; male subjects must agree to use effective contraception from the start of the study until at least 6 months after study drug administration; 10. Patients who have signed the informed consent form and are willing to complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent malignant tumors (except cured malignant tumors with cancer-free survival for more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma, etc.); 2. History of allergy to any component of MRG003; 3. Patients with clinically significant liver disease, such as hepatitis C (positive for hepatitis C antibody) or chronic active hepatitis B (positive for HBsAg for more than 6 months, HBV DNA >=2000 IU/ml, ALT >=2 × ULN, and hepatitis caused by drugs or other causes excluded), alcoholic hepatitis, non-alcoholic steatohepatitis, hepatectomy, liver cirrhosis, etc.; 4. History of immunodeficiency disease, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation; 5. History of the following ophthalmic abnormalities, such as: severe dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other disease that may increase the risk of corneal epithelial damage; 6. Patients with impaired cardiac function or clinically significant heart disease, including but not limited to any of the following conditions: baseline heart rate-corrected QT interval calculated by Fridericia's formula >450 ms, or congenital long QT syndrome; concurrent diseases that may prolong the QT interval as assessed by the investigator, such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV infection, liver cirrhosis, uncontrolled hypothyroidism or heart failure, etc.; history of severe uncontrolled arrhythmia; patients who had myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, heart failure of NYHA class II or above, cerebrovascular accident or transient ischemic attack within 3 months before the first dose; patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 7. Patients with any severe and/or uncontrolled disease or other conditions that, in the opinion of the investigator and sponsor, may affect the patient's participation in this study, including but not limited to the following conditions: uncontrolled diseases, or participation in this study may affect the control of these diseases; history of severe skin disease undergoing targeted therapy; history of interstitial pneumonia, radiation pneumonitis, severe chronic obstructive pulmonary disease, obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm; life-threatening autoimmune diseases and ischemic diseases; 8. Severe infection (CTC AE > grade 2) occurred within 4 weeks before the first use of study drug, active infection during screening, or unexplained fever >38.5°C before administration (tumor-related fever may be considered for enrollment); 9. Received any of the following treatments for HPV-positive oropharyngeal cancer: radiotherapy, chemotherapy, immunotherapy (including PD-1, anti-PD-L1 antibody, anti-CTLA-4 antibody, tumor vaccine, etc.), biological targeted therapy, other clinical studies and other anti-tumor treatments; 10. Simultaneously enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study; 11. Underwent major surgical treatment for any reason within 4 weeks before the first dose and during treatment, or surgery considered necessary by the investigator; 12. Toxi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant Metastasis?free Survival;Locoregional Recurrence?free Survival;Adverse Events;Overall Survival; | — |
Countries
China
Contacts
Public ContactLu Xueguan
Fudan University Shanghai Cancer Center
Outcome results
None listed