Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Carrell beads/chemotherapy + surgery±radiotherapy±chemotherapy + carrell beads
Control group:Surgery±Radiotherapy±Chemotherapy
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years. 2. The primary tumor was the head and neck squamous cell carcinoma(except nasopharyngeal carcinoma), who had received surgery, and / or chemotherapy, and / or radiotherapy in the past. 3. Local recurrence was diagnosed by pathology or MDT. 4. The recurrence tumor can be surgicall removed. 5. No distant metastasis 6. ECOG performance status = 4.0x10^9/L, ANC >= 1.5x10^9/L, PLT>=100x10^9/L, Hb>=90g/L (no blood transfusion and blood products in 14 days, no use Correction of G-CSF and other hematopoietic stimulating factors); (2) Biochemical examination should meet the following standards: serum albumin >= 3.0 g/dL (30 g/L), TBIL = 60ml/min (Cockcroft-Gault formula); (3) Good coagulation function: defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the intended use range of anticoagulation drugs can be included in this experiment; 10. Women of childbearing potential must have a negative ß-HCG pregnancy test within 7 days prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, or to abstain from sexual activity during the study and for at least 2 months after last dose of study drugs. 11. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Patient information and written informed consent form signed.
Exclusion criteria
Exclusion criteria: 1. Patients receiving other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, or other investigational agent prior to the first dose of study drug and while on study treatment. 2. Patient with active autoimmune disease. Subjects with type I diabetes, vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. 3. History of primary immunodeficiency, a known HIV status, active hepatitis B (HBV-DNA >= 10^4 copies/ml) or hepatitis C (positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA). 4. History of hypersensitivity to study drug or any excipients or to other humanized mAbs. 5. The following conditions occurred within 6 months before randomization: myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia and symptomatic congestive heart failure. 6. Live vaccines have been vaccinated within 4 weeks before the first use of the study drug. Inactivated virus vaccines for seasonal influenza and injections are allowed, but live attenuated influenza vaccines for nasal use are not allowed. 7. History of allogeneic organ transplant or allogeneic hematopoietic stem cell transplantation. 8. History of psychotropic drug abuse or narcotic drug abuse. 9. Pregnant or breast-feeding women. 10. History of another primary malignancy within 5 years except for tumors that can be treated locally and cured such as skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast intraductal carcinoma in situ and papillary thyroid carcinoma. 11. Patients with other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study. And the patients that the researchers think are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Two year disease-free survival rate;Overall survival, OS;Disease-free survival, DFS;Pathologic complete response rate, pCRR;Major Pathological Response Rate, mPRR;Distant metastasis-free survival, DMFS;Locoregional recurrence-free survival, LRCS;Safety;Survival depending on biomarkers status;Quality of life (QoL): QLQ-C30, Questionnaire H&N35;Cellular correlates of response and changes in the tumor microenvironment;One year disease-free survival rate;One year overall survival rate;Survival analysis based on pathological reaction;Survival analysis based on clinical characteristics;Survival analysis based on laboratory examination;Survival analysis based on adverse drug reactions;Survival analysis based on tumor immune microenvironment;Survival analysis based on gene characteristics; | — |
Countries
China
Contacts
Public ContactHe Yue, Liu Feng
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed