HPV-positive oropharyngeal squamous cell carcinoma
Conditions
Interventions
Standard CCRT:Radiotherapy: 70 Gy / 35 fractions
Concurrent chemotherapy: Cisplatin 80mg/m2, administered over 3 days, every 3 weeks, for 2 cycles.
Individualized reduced-dose therapy group (Selectively De-escalated CCRT):Initial treatment plan: Radiotherapy: 60Gy/30F
Concurrent chemotherapy: cisplatin 80mg/m2, used over 3 days, Q3W, 2 cycles.
Enhanced MRI scans were performed 4 weeks after the initiation of radiotherapy to assess whether the primary lesion and lym
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 8th edition staging: cT1-4N0-3M0, excluding lymph node iENE grade 3). 2. Pathologically confirmed HPV-associated squamous cell carcinoma by oropharyngeal biopsy, with p16 positivity by immunohistochemistry, and positive expression of high-risk HPV among multiple HPV subtypes. 3. Age 18-75 years, ECOG performance status 0-1. 4. Pretreatment 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. 5. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <=1.5×ULN (for patients on stable doses of anticoagulant therapy such as low-molecular-weight heparin or warfarin, with INR within the expected therapeutic range for anticoagulants, screening may be allowed). 6. Cardiac enzyme levels within the normal range. 7. No prior antitumor therapy (radiotherapy, chemotherapy, immunotherapy, or biological targeted therapy) directed at the tumor lesion. 8. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and agree to use reliable contraception during the study; male subjects must use reliable contraception from the start of treatment until 120 days after the last dose; male subjects must agree to use effective contraceptive measures from the start of the study until at least 6 months after study drug administration. 9. Signed informed consent and willingness to complete the study per protocol.
Exclusion criteria
Exclusion criteria: 1. Prior or concurrent other malignancies (except for those that have been cured and with a cancer-free survival >5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma). 2. History of allergy to cisplatin or other platinum-containing agents. 3. Patients with clinically significant liver disease, such as hepatitis C (positive anti-HCV antibody), or chronic active hepatitis B (HBsAg positive for >6 months, HBV DNA >=2000 IU/mL, ALT >=2× upper limit of normal, and excluding hepatitis caused by drugs or other reasons), alcoholic hepatitis, non-alcoholic steatohepatitis, history of hepatectomy, cirrhosis, etc. 4. Patients with bone marrow suppression, severe renal impairment, excessive fluid loss, chickenpox, herpes zoster, gout, hyperuricemia, or prior peripheral neuropathy caused by cisplatin, for whom cisplatin is contraindicated. 5. Any severe and/or uncontrolled disease or other condition that, in the opinion of the investigator and sponsor, may affect the patient's participation in this study. 6. Prior receipt of any therapy for HPV-positive oropharyngeal cancer, including radiotherapy, chemotherapy, immunotherapy (including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, tumor vaccines, etc.), biological targeted therapy, other clinical research, or other antitumor treatments. 7. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or follow-up of an interventional study. 8. Major surgery for any reason within 4 weeks before treatment or during the treatment period, or surgery deemed necessary by the investigator. 9. Toxicity from prior antitumor therapy not recovered to 1 year ago without adequate treatment. 11. Known history of psychotropic substance abuse, alcoholism, or drug abuse. 12. Pregnant or breastfeeding women. 13. In the investigator's judgment, other factors that may compel the subject to withdraw prematurely from the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, family or social factors, or other circumstances that may affect subject safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant Metastasis free surviva;Overall Survival;Locoregional Recurrence free Survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactLu Xueguan
Fudan University Shanghai Cancer Center
Outcome results
None listed