oral cancer
Conditions
Interventions
High risk of recurrence:Camrelizumab+Chemoradiotherapy
intermediate risk of recurrence :Camrelizumab+radiotherapy
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old, male or female; 2. Patients with a pathologic or clinical diagnosis of oral cancer; 3. Patients with surgically resectable oral cancer who are at high risk for recurrence (e.g., extranodal extension, positive/insufficient surgical margin, T3-4, N2-3, lymph node in region IV or V, vascular invasion, peripheral nerve invasion, lymph node invasion, involving more than 2 lymph node regions); 4. Patients with oral cancer who were assessed by the investigator as requiring adjuvant therapy after surgery; 5. ECOG:0-2; 6. The expected survival time > 12 weeks; 7. The functions of vital organs meet the following requirements: a) Absolute count of neutrophils (ANC) >= 1.5x10^9/L; b) Platelet >= 100x10^9/L; c) Hemoglobin >= 9g/dL; d) Serum albumin >= 2.8g/dL; e) Total bilirubin 60 mL/min(Cockcroft-Gault); g) Activated partial thromboplastin time and international normalized ratio <= 1.5 x ULN (For the use of stable dose anticoagulants such as low molecular weight heparin or warfarin and INR within the intended therapeutic range of anticoagulants can be screened); 8. Fertile female subjects, as well as male subjects whose partners are of pre-reproductive age, will be required to use a medically approved contraceptive method (e.g. intrauterine device, contraceptive pill, or condom) during the study treatment period and at least 3 months after the last use of Camrelizumab; 9. Subjects volunteered to participate in this study, signed the informed consent, and showed good compliance and follow-up; 10. Researchers believe that patients can benefit from this study.
Exclusion criteria
Exclusion criteria: 1. Previous allergy to Camrelizumab, Cisplatin or any other component; 2. Patients with contraindications to radiotherapy; 3. Has received any of the following treatments: a) Previous treatment with anti-PD-1 or anti-PD-L1 antibodies; b) Had received any research drug within 4 weeks prior to initial study drug use; c) Subjects requiring systematic treatment with corticosteroids (> equivalent dose of 10mg/d prednisone per day) or other immunosuppressant within 2 weeks prior to initial use of the study drug, except for corticosteroids for local inflammation of the esophagus and for the prevention of allergy and nausea and vomiting.Other special circumstances, need to communicate with the sponsor.In the absence of active autoimmune disease, inhaled or topical corticosteroid replacement with a therapeutic dose of > 10mg/d prednisone is allowed; d) Those who have received an anti-tumor vaccine or have received a live vaccine within 4 weeks prior to the first administration of the research drug; e) Major surgery or severe trauma within 4 weeks prior to initial study drug use; f) Enroll in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or an intervention studies follow-up study; 4. Have a history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); With the exception of vitiligo or cured childhood asthma/allergies without any intervention in adults;Autoimmune-mediated hypothyroidism treated with a steady dose of thyroid replacement hormone; Type 1 diabetes mellitus using a steady dose of insulin; 5. Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation; 6. Severe infections (CTCAE > grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization;Baseline chest imaging studies suggest the presence of active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in the case of prophylactic antibiotics; 7. A history of interstitial lung disease (except for radiation pneumonia without hormone therapy) and a history of non-infectious pneumonia; 8. Patients who had an active TB infection by history or CT examination, or had an active TB infection within 1 year prior to enrolment, or had an active TB infection more than 1 year prior to enrolment but had not received formal treatment; 9. Untreated active hepatitis (HBV DNA >= 2000 IU/mL or 10^4 copies/mL), hepatitis C (HCV antibody positive and HCV-RNA >= 10^3 copies/mL or antiviral therapy required during study period); 10. No other malignancies were diagnosed within 5 years prior to the first use of the study drug, except for those with a low risk of metastasis and death (5-year survival rate of > 90%), such as adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ; 11. Pregnant or lactating women; 12. As determined by the Investigator, subjects may have other factors that may cause them to be forced to terminate the study, such as other serious medical con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three year of disease free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence-free survival;Distant metastasis free survival;disease free survival;overall survival;safety; | — |
Countries
China
Contacts
Public ContactShaoqing Chen
The First Affiliated Hospital of Nanchang University
Outcome results
None listed