oral squamous cell carcinoma
Conditions
Interventions
experimental group:AK112 in combination with chemotherapy (AK112 plus carboplatin plus pemetrexed/paclitaxel, or AK112 plus docetaxel)
Sponsors
The first affiliated hostipal of nanchang university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Prior to conducting any trial-related procedures, the subject shall sign the written informed consent; 2. Male or female, aged >= 18 years and =3 months. 8. Patients with at least one evaluable lesion in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. 9. Sufficient organ function, and the subjects must meet the following laboratory parameters: Hematology: White blood cell (WBC) count >= 4,000/µL, neutrophil count >= 2,000/µL, hemoglobin (Hb) >= 9 g/dL, platelet count >= 100,000/µL. Hepatic function: Total bilirubin = 3 g/dL. Renal function: Serum creatinine = 60 mL/min calculated by the Cockcroft-Gault formula. 10. Patients who are able to comply with the scheduled study visits, treatment plans, laboratory examinations and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with pathological histologic types other than squamous cell carcinoma (e.g., adenocarcinoma, etc.). 2. A history of severe hypersensitivity to any component of anti-PD-1 monoclonal antibody or bevacizumab. 3. Having contraindications to, or a history of hypersensitivity to the combined chemotherapeutic drugs. 4. Presence of unresectable factors, including unresectability due to tumor-related reasons, existing surgical contraindications, or refusal of surgery by the subject. 5. Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures. 6. Recurrent tumors, distant metastasis, or concomitant other malignant tumors. 7. Patients with laboratory test results that fail to meet the relevant criteria within 7 days prior to enrollment. 8. Subjects with a history of prior immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), adoptive cellular immunotherapy and any other anti-tumor therapies with immunological mechanisms of action. 9. Having received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use for pleural effusion control) within 2 weeks prior to the first dose of study treatment. 10. Having comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic/local administration of corticosteroids at immunosuppressive doses prior to enrollment. 11. HIV-positive subjects; HBsAg-positive subjects with positive HBV DNA copy number (quantitative test = 1000 cps/ml); positive screening for chronic hepatitis C (HCV antibody positive). 12. Pregnant or lactating women. 13. Presence of any severe or uncontrolled systemic diseases, including but not limited to: (1) Significant and poorly controlled symptomatic abnormalities in cardiac rhythm, conduction or morphology on resting electrocardiogram (ECG), such as complete left bundle branch block, atrioventricular block of grade ? or higher, ventricular arrhythmia or atrial fibrillation. (2) A history of myocarditis, cardiomyopathy or malignant arrhythmia. A history of unstable angina pectoris requiring hospitalization, myocardial infarction, congestive heart failure or vascular diseases (e.g., aortic aneurysm with rupture risk) within 12 months prior to the first dose, or other cardiac impairments that may affect the safety evaluation of the study drug (e.g., uncontrolled arrhythmia, myocardial infarction or myocardial ischemia, etc.). (3) A history of esophagogastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose. (4) An acute exacerbation of chronic obstructive pulmonary disease (COPD) within 1 month prior to the first dose. (5) Any arterial thromboembolic event, venous thromboembolic event of grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, transient ischemic attack (TIA), cerebrovascular accident, hypertensive crisis or hypertensive encephalopathy within 6 months prior to the first dose; current hypertension with systolic blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Event-Free Survival (EFS);Pathological Complete Response (pCR) rate;R0 Resection Rate;Objective Response Rate (ORR) Assessed According to RECIST Version 1.1;Clinical Downstaging Rate (T and/or N Downstaging);Disease-Free Survival (DFS); | — |
Countries
China
Contacts
Public ContactZhang Jie
The first affiliated hostipal of nanchang university
Outcome results
None listed