Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Carrelide/Chemo + Surgery ± RT ± Chemo + Carrel
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. The primary tumor is head and neck squamous cell carcinoma (except nasopharyngeal carcinoma), initial unresectable or recurrent locally advanced head and neck squamous cell carcinoma (definition of local or regional recurrence: including local recurrence and regional lymph node metastasis); 3. Local recurrence diagnosed by pathology or MDT; 4. No distant metastasis; 5. ECOG score 0-1 points; 6. Willing to accept reoperation after induction therapy; 7. No obvious contraindications to immunotherapy and radiotherapy and chemotherapy; 8. The level of major organ function meets the following criteria: (1) The blood routine examination standards must meet: WBC>=4.0x10^9/L, ANC>=1.5x10^9/L, PLT>=100x10^9/L, Hb>=90g/L (No blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors); (2) Biochemical tests should meet the following criteria: serum albumin >= 3.0 g/dL (30 g/L), TBIL=60ml/min (Cockcroft-Gault formula); (3) Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the PT is within the intended use range of the anticoagulant drug; 9. Women of childbearing age must have taken reliable contraceptive measures, performed a pregnancy test within 7 days before enrollment, and the result is negative, and be willing to use effective contraception during the trial and within 2 months after the last administration of anti-PD-1 antibody. For male subjects whose partners are women of childbearing age, effective contraception should be used during the trial and within 2 months after the last dose of anti-PD-1 antibody; 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received anti-PD-1/PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, CTLA-4 antibody, or other drugs/antibodies acting on T cell costimulation or checkpoint pathway; 2. There is a severe active autoimmune disease. Subjects who are stable and do not require systemic immunosuppressive therapy, such as: type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic therapy (eg, vitiligo, psoriasis, and alopecia); 3. Suffering from congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B (HBV-DNA >= 10^4 copies/ml) or hepatitis C (positive hepatitis C antibody, and HCR-RNA is higher than the detection limit of the analytical method) ; 4. Known allergy to the study drug or any of its excipients; or have had a severe allergic reaction to other monoclonal antibodies; 5. Within 6 months prior to randomization, the following conditions have occurred: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, and symptomatic congestive heart failure.; 6. Those who have been vaccinated with live vaccines within 4 weeks before the first use of the study drug are allowed to receive inactivated virus vaccines for seasonal influenza and injections, but they are not allowed to receive live attenuated influenza vaccines for nasal use; 7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Known history of psychotropic substance abuse or drug use; 9. Lactating subjects; 10. Diagnosed with any other malignant tumor within 5 years prior to study entry, except for locally treatable and cured basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary thyroid carcinoma; 11. There are other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, and subjects who are considered unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| surgery resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;1- and 2-year overall survival;overall survival; | — |
Countries
China
Contacts
Public ContactLiu Feng
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed