melanoma
Conditions
Interventions
Adbelizumab + dacarbazine + cisplatin:Eligible patients received adbelizumab (1200mg, D1, Q3w) in combination with dacarbazine
(250mg/m2, D1-D5, Q3w or 850mg/m2, D1, Q3w) and cisplatin (25mg/m2, D1-D3
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Histologically confirmed patients with stage III/IV acromelanomas that cannot be resected or metastasized, or that have recurred after surgery; 3.ECOG PS score 0-1; 4. The expected survival period is more than 3 months; 5. There is at least one measurable solid tumor lesion without prior systematic antitumor therapy; 6. Dacarbazine + carboplatin recurred after half a year of first-line chemotherapy; 7. The functions of vital organs meet the following requirements: (1) Blood routine: white blood cell count (WBC) =3.0×109/L; Absolute neutrophil count (ANC)1.5 x 10 or higher9/L; Platelet (PLT) =100×109/L; Hemoglobin content (HGB) = 9.0g /dL (no corresponding blood transfusion, leukocyte upgrading and other supportive treatment within 7 days);(2) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase were transferred in patients without liver metastasisEnzyme (ALT) =2.5 ULN, ALT and AST=5 ULN in patients with liver metastasis; Serum total bilirubin (TBIL)=1.5 ULN (except Gilbert syndrome with total bilirubin < 3.0 mg/dL); Albumin (ALB) =30g/L,Alkaline phosphatase (ALP) =2.5×ULN, bone metastasis patients, ALP=5×ULN;(3) Renal function: serum creatinine =1.5 times ULN or creatinine clearance (CrCl) =50 mL/min (use Cockcroft/Gault formula); Urinary protein (UPRO) < (++), or 24-hour urinary protein volume < 1.0 g;(4) Coagulation function: International standardized ratio (INR) =1.5 and activated partial thromboplastin time (APTT)=1.5 times ULN; If the patient is receiving anticoagulant therapy, the anticoagulant should be used as long as PT or APTT is expected Within the scope of treatment, refer to the relevant drug instructions;(5) Thyroid stimulating hormone (TSH)= upper limit of normal (ULN), if abnormal, T3 and T4 levels should be investigated.Normal levels of T3 and T4 can be selected.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included); 2. Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment; 3. Severe allergic reaction to other monoclonal antibodies; 4. Exclude BRAF V600 gene mutation; 5. Have clinical symptoms or diseases of heart that are not well controlled, such as: NYHA2 or above heart failure; Unstable angina pectoris; Myocardial infarction within 1 year; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; QTc>450ms(male); QTc>470ms(female); 6. Patients who had previously received radiotherapy, chemotherapy, hormone therapy, or surgery, and were treated less than 4 weeks after completion of treatment (last dose) before study medication; Patients whose molecular targeted therapy (including other oral targeted drugs used in clinical trials) has a half-life of 15×109/L at baseline; Or have suppurative and chronic infection, prolonged wound does not heal; 8. For patients with bone metastases, the area of palliative radiotherapy received in the 4 weeks prior to joining the study was >5% of the bone marrow area; 9. The patient had previously received anti-PD-1, anti-PD-L1, and anti-PD-L2 therapy; 10. People who are known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 11. Cutaneous melanoma, ocular melanoma, primary unknown melanoma; 12. Pregnant or lactating women, or female patients who are fertile but do not take contraceptive measures; 13. Patients with other malignant tumors; 14. Patients participating in other clinical trials at the same time; 15. HIV positive; HCV positive; HBsAg or HBcAb positive patients also detected HBV DNA copy number positive (quantitative detection limit of 500IU/ml); 16. Those who received live vaccination within 4 weeks before the start of treatment; 17. Other severe, acute, or chronic medical or psychiatric disorders or laboratory abnormalities that, according to the investigator, may increase the risks associated with participation in the study or may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Overall survival (OS);Disease control rate (DCR);Safety: including treatment-related adverse events (AES), serious adverse events (SAEs); Investigational drug The incidence of associated AE and SAE, and deaths that occurred during the study period, were judged according to NCI-CTCAE 5.0 standards Break;; | — |
Countries
China
Contacts
Public ContactTaiying Lu
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed