melanoma
Conditions
Interventions
Trial Arm (ARM A):Carelizumab: D1 and D15 Carrelizumab 200 mg/dose, every 2 weeks
4 weeks as a cycle (i.e. 28 days), totaling 12 cycles
Temozolomide: D1~D5, the dose is 200 mg/m2 each time for 5 consecutive days, and stop for 23 days, 28 days as a cycle, a total of 6 cycles
Radiation: Within 12 weeks after lymph node dissection, adjuvant radiotherapy should be performed on the postoperative lymph node drainage basin. The radiotherapy adopts intensity modulated conformal
Control ARM (ARM B):Carelizumab: D1 and D15 Carrelizumab 200 mg/dose, every 2 weeks
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria in order to be enrolled in this study: 1. Acral melanoma patients diagnosed clinically or pathologically as IIIC-IIID (gross lymph node metastasis) (according to AJCC TNM 8th Edition, 2017) 2. Age range from 18 to 75 years old, both male and female; 3. At baseline, enough samples can be obtained for exon and transcriptome sequencing, and they are willing to accept ctDNA detection in peripheral blood during treatment; 4. The ECOG score is 0 or 1; 5. Subjects with chronic HBV infection must have HBV-DNA<500 IU/mL, and HBsAg positive patients must receive antiviral treatment in accordance with the 2015 edition of the Chronic Hepatitis B Prevention and Treatment Guidelines. HCV-RNA positive patients must receive antiviral treatment in accordance with the "Guidelines for the Prevention and Treatment of Hepatitis C, 2015" and their liver function must be within normal range 6. If the main organs function normally, they meet the following standards: 1) Blood routine examination (no blood transfusion or use of hematopoietic stimulating factors within 14 days before screening): HB = 90 g/L; ANC = 1.5*109 /L; PLT = 100*109 /L 2) Blood biochemical test (no blood transfusion within 14 days before screening): ALB = 29 g/L; ALT and AST<2.5 ULN; TBIL = 1.5 ULN; Creatinine = 1.5 ULN; TSH = 1.0 ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group) 3) International Standardization Ratio (INR) = 2.0 7. Female patients who have not undergone surgical sterilization or are of childbearing age are required to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of the study treatment period; Non surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 72 hours before enrollment in the study; For male patients whose partners are women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last administration of Carolizumab 8. The patient voluntarily joined this study and signed an informed consent form;
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions will be excluded from the trial: 1. Patients with cutaneous, mucosal, uveal melanoma or unknown primary lesion diagnosed clinically or pathologically; 2. Patients with in transit disease at baseline; 3. Those with severe local invasion of the primary lesion of malignant melanoma and a risk of organ leakage, major bleeding, or perforation; 4. The patient has any active autoimmune disease or a history of autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included) 5. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones) and continues to use them within 2 weeks before enrollment; 6. Suffering from hypertension and unable to achieve good control through antihypertensive medication treatment (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg); 7. Clinical symptoms or diseases of the heart that cannot be well controlled, such as: 1) NYHA grade 2 or above heart failure 2) Unstable angina pectoris 3) Have experienced myocardial infarction within 1 year 4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention 5) QTc>450ms (male); QTc>470ms (female); 8. Abnormal coagulation function (INR>2.0, PT>16s), with bleeding tendency or undergoing thrombolysis or anticoagulation treatment, allowing prophylactic use of low-dose aspirin and low molecular weight heparin; 9. Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies, such as cough/hemoptysis of 2.5 mL or more of lower gastrointestinal bleeding, esophageal and gastric varices at risk of bleeding, hemorrhagic gastric ulcers, or vasculitis; 10. Arterial/venous thrombotic events occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 11. Known genetic or acquired bleeding and thrombotic tendencies (such as hemophilic patients, coagulation dysfunction, thrombocytopenia, etc.); 12. Urinary routine tests indicate that urine protein is =++and it has been confirmed that the 24-hour urine protein content is>1.0 g; 13. The patient has active infection, unexplained fever = 38.5 ° C within 7 days before medication, or baseline white blood cell count>15 × 109/L; Those who may have purulent or chronic infections, and the wound persists without healing; 14. HIV positive; HCV positive; HBsAg or HBcAb positive individuals simultaneously detected HBV DNA copy number positive (quantitative detection limit of 500IU/ml); 15. Pregnant or lactating women, or female patients with fertility who have not taken contraceptive measures; 16. Known to be allergic to recombinant humanized anti PD-1 monoclonal antibody drugs and their components, Temozolomide; 17. Patients who used Temozolomide within 6 months before enrollment; 18. Those who also suffer from other malignant tumors; 19. Patients who participate in other clinic
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Rate;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| 1-year relapse-free survival rate; | — |
Countries
China
Contacts
Public ContactYU XU
Fudan University Shanghai Cancer Center
Outcome results
None listed