Clinical stage IVB oral squamous cell carcinoma or HPV-negative oropharyngeal squamous cell carcinoma
Conditions
Interventions
Neoadjuvant ADC combined with cisplatin and immunotherapy (single-arm):Neoadjuvant ADC combined with cisplatin and immunotherapy
Sponsors
Hospital of Stomatology Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 Years, Male Or Female. 2. Patients With Histologically Or Cytologically Confirmed Oral Squamous Cell Carcinoma And HPV-Negative Oropharyngeal Squamous Cell Carcinoma (Confirmed By Negative P16 Immunohistochemistry). 3. No Prior Treatment For Oral Squamous Cell Carcinoma / HPV-Negative Oropharyngeal Squamous Cell Carcinoma. 4. Clinical Stage IVB According To The AJCC TNM Staging System (8Th Edition). 5. ECOG Performance Status 0–1. 6. Expected Survival >=12 Weeks. 7. Adequate Major Organ Function And Laboratory Test Results Meeting The Following Criteria: (1) Hematology: Absolute Neutrophil Count >=1.5×10^9/L (Or Above The Lower Limit Of Normal Of The Study Center’s Laboratory), Platelet Count >=100×10^9/L, Hemoglobin >=90 G/L. (2) Liver Function: Serum Total Bilirubin =60 mL/min/1.73 m^2 (Calculated Using The Cockcroft-Gault Formula). 8. Willing To Voluntarily Participate In This Study, Sign The Informed Consent Form, Have Good Compliance, And Cooperate With Follow-Up. 9. The Investigator Judges That The Patient Can Comply With The Study Protocol. 10. Negative Pregnancy Test At Screening (For Female Patients Of Childbearing Potential). 11. Male Patients With Reproductive Potential And Female Patients Of Childbearing Potential And At Risk Of Pregnancy Must Agree To Use Two Methods Of Contraception (At Least One Of Which Is Considered Highly Effective) Throughout The Study Period. Female Patients Not Of Childbearing Potential (Meeting At Least One Of The Following Criteria): – Have Undergone Hysterectomy And/Or Bilateral Oophorectomy With Documented Records; – Have Medically Confirmed Ovarian Failure; – Are Postmenopausal, Defined As At Least 12 Consecutive Months Of Amenorrhea Without Other Pathological Or Physiological Causes, With Serum Follicle-Stimulating Hormone (FSH) Levels Consistent With The Postmenopausal State. 12. Signed And Dated Informed Consent Form Indicating That The Patient (Or Legal Representative, If Permitted By Local Guidelines/Practice) Has Been Informed Of All Relevant Aspects Of The Study. 13. Patients Who Are Willing And Able To Comply With Scheduled Visits, Treatment Plans, Laboratory Tests, And Other Study Procedures.
Exclusion criteria
Exclusion criteria: 1. Prior Immunotherapy With Anti-PD-1, Anti-PD-L1, Anti-PD-L2, Anti-CD137, Or Anti-CTLA-4 Antibodies (Including Ipilimumab), Or Any Other Antibodies Or Drugs Specifically Targeting T-Cell Co-Stimulation Or Immune Checkpoint Pathways. 2. Major Surgery =10^4 Copies/mL Or 2000 IU/mL), Or Hepatitis C (Positive For HCV Antibody With HCV-RNA Above The Lower Limit Of Detection Of The Assay). 10. Prior Other Oncology-Specific Treatment Before Study Enrollment. 11. Vaccination With Live Vaccine Within 4 Weeks Before Start Of Study Treatment. 12. Known History Of Psychoactive Substance Abuse, Alcoholism, Or Drug Addiction. 13. Pregnant Or Breastfeeding Women. 14. In The Investigator’s Judgment, Any Other Condition That May Compel The Patient To Terminate The Study Prematurely, Such As Other Serious Diseases (Including Psychiatric Disorders) Requiring Concomitant Therapy, Severely Abnormal Laboratory Values, Family Or Social Factors That Could Affect Patient Safety Or Collection Of Study Data. 15. Active Pulmonary Tuberculosis. 16. Severe Infection Within 4 Weeks Before Start Of Study Treatment (Including But Not Limited To Hospitalization For Infection, Bacteremia, Or Complications Of Severe Pneumonia). 17. Receipt Of Systemic Immunostimulatory Drugs (Including But Not Limited To Interferon Or Interleukin-2 [IL-2]) Within 4 Weeks Before Start Of Study Treatment, Or Still Within Five Half-Lives Of The Drug (Whichever Is Longer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Quality of Life Score (EORTC QLQ C30 & EORTC QLQ H&N35);Pathological Complete Response Rate (pCR Rate);Major Pathological Response Rate (MPR Rate);R0 Resection Rate;Treatment-Related Adverse Event (TRAE) Safety Assessment;2-year Event-Free Survival Rate (2y-EFS Rate);2-year Disease-Free Survival Rate (2y-DFS Rate);2-year Overall Survival Rate (2y-OS Rate); | — |
Countries
China
Contacts
Public ContactJun Jia
Hospital of Stomatology Wuhan University
Outcome results
None listed