Salivary gland carcinoma?
Conditions
Interventions
Experimental group:Cadonilimab combined with chemotherapy?
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University?
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this trial, be able to provide written informed consent, and understand and agree to comply with the requirements of the study and the evaluation schedule. 2. Be at least 18 years of age on the date of signing the informed consent form. 3. Patients with histopathologically or cytohistologically confirmed high-grade salivary gland carcinoma, including solid > 30% poorly differentiated carcinoma, high-grade mucoepidermoid carcinoma, high-grade pleomorphic adenocarcinoma, lymphoepithelial carcinoma, ductal carcinoma of the salivary gland, high-grade myoepithelial carcinoma, carcinosarcoma, and high-grade adenocarcinoma. 4. Confirmation of at least 1 measurable lesion based on CT, MRI or PET-CT 21 days prior to dosing. 5. ECOG fitness status of >1 or Karnofsky fitness status of 80%. 6. Resectable salivary gland tumour (T3-4a, N0-2, AJCC 8th.). 7. Tumour tissue samples from radical surgery must be provided, along with a pathology report, either fresh surgical tissue (>=50mg, tumour cell content >=20%.) or white slices (>=20%.). Or send a pathology white slice (FFPE tissue block or 20 freshly cut unstained FFPE tissue sections with tumour cell content >=20%). 8. Patients with good organ function as measured by the following screening laboratory values (obtained = 1.5x10^9/L Platelets >=100*10^9/L Haemoglobin >=90g/L (2) International normalised ratio or activated partial thromboplastin time = 50% of predicted value, DLCO >= 40%. 9.Male or female subjects should agree to use an appropriate method of contraception from the first dose of study treatment until 6 months after the last dose of the study (e.g., IUD, birth control pills, or condoms); be free of pregnant or lactating women and have received a negative pregnancy test within 7 days prior to randomisation to group.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any immune-checkpoint inhibitor (anti-PD-1/PD-L1, anti-CTLA-4, or bispecific antibodies). 2. Imaging (CT or MRI) showing tumor encasing the internal carotid artery for > 180°or invading the skull base. 3. Evidence or history of bleeding diathesis within 2 months before first dose, or hemoptysis within 2 weeks, or unhealed wound, ulcer, or fracture. 4.Active severe autoimmune disease. Stable conditions not requiring systemic immunosuppression are permitted (e.g., type I diabetes, hypothyroidism on replacement therapy, vitiligo, psoriasis, or alopecia not requiring systemic therapy). 5. Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV DNA >= 10^4 copies/mL), or active hepatitis C (anti-HCV positive and HCV RNA detectable). 6. Known hypersensitivity to any study drug component or previous severe allergic reaction to another monoclonal antibody. 7. Within 6 months before randomization: myocardial infarction, severe/unstable angina, NYHA class >= 2 heart failure, or symptomatic congestive heart failure. 8. Live-virus vaccination within 4 weeks before first dose (inactivated influenza vaccine by injection is allowed; intranasal live attenuated influenza vaccine is not). 9. Prior allogeneic organ or hematopoietic stem-cell transplantation. 10. History of substance abuse (drugs or alcohol) or psychiatric disorder that may interfere with study compliance. 11. Pregnant or lactating women. 12. Any other malignancy within 5 years except adequately treated basal- or squamous-cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ, or papillary thyroid carcinoma. 13. Any concurrent severe medical or laboratory abnormality that, in the investigator’s opinion, could increase study-related risk, interfere with data interpretation, or render the patient unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;pathological complete response;Objective Response Rate;Event-Free Survival rate;Overall survival rate;Treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactZhaoyu Lin
Sun Yat-sen Memorial Hospital, Sun Yat-sen University?
Outcome results
None listed