Locally Advanced Laryngeal Cancer
Conditions
Interventions
Research group:Induction therapy with Becotatug Vedotin and Pucotenlimab, 2 cycles
Sponsors
Eye & ENT Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed laryngeal squamous cell carcinoma; 2. Age: 18-70 years; male or female; 3. AJCC 8th edition stage T3-4aN0-3bM0; 4. At least one measurable lesion according to RECIST 1.1 criteria; 5. No prior neoadjuvant antitumor therapy for laryngeal cancer; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 7. Life expectancy >=6 months; 8. Organ function meeting the following criteria within 14 days before the first dose: ANC >=1.5×10?/L, PLT >=100×10?/L, HGB >=90 g/L; Liver function: ALT, AST =50 mL/min (Cockcroft-Gault formula); INR, APTT 50% by echocardiography; 9. HBV DNA <500 IU/mL (or 2500 copies/mL) and HCV RNA negative; 10. Signed informed consent form; 11. The investigator anticipates good compliance of the patient and their family, and willingness and ability to follow the treatment plan, laboratory tests, visit schedule, and other study procedures; 12. Negative pregnancy test (for female patients of childbearing potential) at screening; male patients with reproductive potential and female patients with childbearing potential or at risk of pregnancy must agree to use contraception throughout the study and for at least 6 months after the last dose of platinum.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastatic lesions; 2. Primary lesion unsuitable for radical surgery, unable to achieve R0 resection; 3. History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, early-stage prostate cancer, differentiated thyroid carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix; 4. Primary sites previously treated with radiotherapy or radical surgery, excluding biopsy for diagnostic purposes; 5. Prior chemotherapy, immunotherapy, or molecular targeted therapy for the primary sites; 6. Participation in any other clinical trials within 4 weeks prior to this study; 7. Any of the following conditions within the past 6 months: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism; 8. Patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg); 9. Coronary heart disease above Grade I, arrhythmia (including QTc interval prolongation >450 ms in males, >470 ms in females), or cardiac insufficiency; 10. Patients with positive urine protein (Urinary protein was greater than ++ and 24-hour urinary protein quantification > 1.0 g); 11. Patients with a history of severe allergy or allergic constitution; active autoimmune disease that may deteriorate when receiving immunostimulants. Patients with type I diabetes, vitiligo, psoriasis, or hypo- or hyperthyroidism that do not require immunosuppressive treatment are eligible for the study; 12. Subjects requiring systemic treatment with corticosteroids (>10 mg prednisone or equivalent per day) or other immunosuppressive agents within 2 weeks prior to the first dose of study drug; 13. Previous diagnosis of immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases. Hepatitis B virus (HBV) surface antigen positive with HBV-DNA=500 IU/mL (or 2500 copies/mL), or HCV RNA positive. Active or prior history of pulmonary tuberculosis (TB); 14. Patients with a history of psychoactive substance abuse that cannot be discontinued, or patients with psychiatric disorders; 15. Vaccination within 4 weeks prior to randomization, except for inactivated vaccines; 16. Pregnant or lactating women, or women of childbearing potential not using effective contraceptive measures; 17. Patients considered by the investigator to be unsuitable for participation in this trial, such as those with severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or laboratory abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One year larynx preservsation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Major pathologic response;1 and 3 year event free survival;1 and 3 year disease free survival;1 and 3 year overall survival;1 and 3 year distant metastasis free Survival;Safety;Quality of life;Laryngeal function; | — |
Countries
China
Contacts
Public ContactLiang Zhou, Hongli Gong, Shu Tian
Eye & ENT Hospital, Fudan University
Outcome results
None listed