melanoma
Conditions
Interventions
experimental group:paclitaxel (albumin-binding) combined with carboplatin and PD1(Pablizumab)
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 to 80 years; 2. Confirmed by histopathology as a primary reproductive tract melanoma patient; 3. Patients who have received first-line treatment and the lesions persist or relapse after treatment; 4. 5 formalin fixed, paraffin-embedded tumor tissue sections were used for biomarker analysis if recurrent lesions were obtained (not required); 5. Adverse reactions caused by previous treatments, such as toxicity of chemotherapy and immunotherapy, and surgical complications, have recovered, or do not affect the evaluation of research results; 6. Patients with at least 1 measurable lesion (RECIST version 1.1); 7. ECOG physical condition score 0-1; 8. Expected survival time >=12 weeks; 9. Bone marrow function: Neutrophil >1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=90g/L; 10. Liver and kidney function: serum creatinine <=1.5 ULN; AST and ALT <=2.5 ULN or <=5 ULN in the presence of liver metastasis; Total bilirubin <=1.5 ULN, or Gilbert's syndrome <=2.5 ULN; 11. Subjects of childbearing age must agree to use effective contraceptives during the study period; A serum or urine pregnancy test must be negative in women of childbearing age; 12. Non-lactating patients; 13. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with central nervous system disease or brain metastasis; 2. Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; 3. Had Grade>=2 sensory or motor neuropathy in the past; 4. The investigator believes that the subject's ability to receive treatment under the study protocol will be affected by uncontrolled serious medical diseases, such as complicated serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; 5. Allergic, highly sensitive or intolerant to the studied drugs or their excipients; 6. Received other experimental drugs or participated in clinical studies for other anticancer therapeutic purposes within 30 days before the first chemotherapy; 7. Severe infections, including but not limited to infectious complications requiring hospitalization, bacteremia or severe pneumonia, occurred within 4 weeks prior to the start of study treatment; 8. Previously received anti-programmed death factor-1 (PD-1), anti-PD-L1, anti-CD137 and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody therapy; 9. A confirmed immunodeficiency disease or being treated with general steroids or other immunosuppressive agents 7 days before receiving the study drug; 10. Patients with active tuberculosis; 11. Human immunodeficiency virus (HIV) positive; 12. HBsAg positive subjects with peripheral blood hbv-dna titer >=1x10^3 IU/mL;If HBsAg positive and hbV-DNA in peripheral blood <1x10^3 IU/mL, the subject is eligible for inclusion if the investigator believes that the subject's chronic hepatitis B is stable and does not increase the subject's risk; 13. Positive for hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody, and positive for HCV RNA test; 14. The researchers judged the patients who were not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFI;OS;PFS;safety; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center
Outcome results
None listed