Head and neck adenoid cystic carcinoma
Conditions
Interventions
Experimental group:Chemotherapy + Targeted therapy + Immunotherapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adenoid cystic carcinoma confirmed by pathological examination, with stage cT3-4N0-2M0; 2. Newly diagnosed patients, or recurrent patients who have undergone simple surgical resection (excluding diagnostic biopsies) for adenoid cystic carcinoma; 3. Have not received any systemic or local treatment for any other head and neck tumors except adenoid cystic carcinoma; 4. Evaluated by the investigator as potentially operable; 5. Male or female, aged >= 18 years and 6 months; 9. Adequate organ function; 10. Signed informed consent form, willing and able to comply with the study visit, treatment plan, laboratory tests and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Has received radiotherapy, chemotherapy, targeted therapy or immunotherapy for adenoid cystic carcinoma; 2. Has distant metastasis; 3. Had any condition requiring systemic corticosteroid treatment (dose higher than 10mg/day of prednisone or equivalent dose of other immunosuppressants) or other immunosuppressive agent treatment within 14 days before treatment; 4. Had uncontrolled diabetes or laboratory test abnormalities of potassium, sodium or corrected calcium levels > grade 1 or >= grade 3 hypoproteinemia within 14 days before treatment; 5. Has the following disease history: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, etc.; 6. Had severe chronic or active infections requiring systemic antibiotics, antibacterial or antiviral treatment (including tuberculosis infection, etc.) within 14 days before the administration of the study drug; 7. Has HIV history or is in the active stage of syphilis; 8. Un-treated chronic hepatitis B patients or chronic HBV carriers with HBV DNA >= 500IU/mL or active hepatitis C virus carriers (HCV) should be excluded. Note: Non-active hepatitis B surface antigen (HBsAg) carriers, stable hepatitis B patients treated and in remission (HBVDNA < 500IU/mL) and cured hepatitis C patients can be included; 9. Has a history of severe hypersensitivity reaction to other monoclonal antibodies; 10. Has any contraindications for the use of the study drug (sulurelin, anlotinib, albumin paclitaxel or carboplatin); 11. Patients with toxicity (caused by previous anti-cancer treatment) have not returned to baseline level or are stable, unless it is an AE that is not considered a possible safety risk (such as hair loss, neuropathy or specific laboratory abnormalities); 12. Pregnant or lactating women; 13. Participating in another therapeutic clinical study simultaneously
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Duration of response;R0 resection conversion rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactSong Ming;Guo Guifang
Sun Yat-sen University Cancer Center
Outcome results
None listed