Advanced malignant melanoma
Conditions
Interventions
Experimental group:ISABR combined with thalidomide
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-65 years, regardless of sex. 2) patients with advanced melanoma who had previously failed or unresectable systemic therapy, who were diagnosed as melanoma by pathology or cytology, and without BRAF V600 gene mutation. 3) at least one measurable lesion (RESIST 1.1). 4) at least one discontinuous lesion is suitable for the imaging examination of the objective response rate of the focus in the field. 5) the ECOG physical condition score was 0-1 (within 3 days before the start of treatment), the expected survival time was more than 3 months, and the function of major organs was basically normal. 6) the laboratory conditions are met: A. Blood routine examination: hemoglobin (Hb) >= 90g/L (no blood transfusion within 14 days), absolute neutrophil count (NEUT) >= 1.5 x 10 ^ 9 / L, platelet (PLT) >= 100 x 10 ^ 9 / L. B. Biochemical examination: pyruvic transaminase (ALT) and aspartate aminotransferase (AST) 50umol/L. The patient voluntarily joined the study, signed the informed consent form, and had good compliance.
Exclusion criteria
Exclusion criteria: 1) Patients with thalidomide allergy. 2) pregnant or lactating women. 3) unable to take medicine or follow up as planned. 4) during the trial and within 3 months after the end of the trial, the subjects and their partners were unwilling to have contraception. 5) patients with adverse reactions above III grade or severe allergic reactions during previous PD-1 antibody treatment. 6) patients with multiple factors affecting oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.). 7) uncontrollable pleural effusion, pericardial effusion and ascites requiring repeated drainage. 8) have received approved or under-studied antineoplastic therapy within 4 weeks before the start of the study, including, but not limited to, chemotherapy, surgery, radiotherapy, biological targeted therapy, interventional therapy, immunotherapy and anti-tumor traditional Chinese medicine therapy (subject to the indications of traditional Chinese medicine instructions, for example, you can also be included in the group after 2 weeks of washing), etc. (note: oral targeted drugs with less than 5 drug half-lives. Or oral fluorouracil less than 14 days, mitomycin C and nitrosourea less than 6 weeks; previous treatment bow adverse events (except hair loss) did not recover to = CTCAE 1 degree). 9) patients with any severe and / or uncontrolled diseases, including. A) patients with unsatisfactory blood pressure control (systolic blood pressure >= 150mmHg or diastolic blood pressure >= 90mmHg). B) unstable angina pectoris, myocardial infarction, grade 2 congestive heart failure or arrhythmias requiring treatment within 6 months of the first administration (including QTC >= 480ms). 10) vaccinated with prophylactic or attenuated vaccine within 4 weeks of the first administration. 11) those who were inoculated with granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 4 weeks after the first administration. 12) the researchers determined that the subjects had other factors that might lead to the termination of the study, such as other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors, and so on. It will affect the safety of the subjects, or the collection of materials and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;mOS;QOL; | — |
Countries
China
Contacts
Public ContactChen ju hui
Fujian Cancer Hospital
Outcome results
None listed