Melanoma
Conditions
Brief summary
It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.
Interventions
DRUGSHR1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
DRUGapatinib mesylate
apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).
Temozolomide is an imidazole tetrazine derivative of the alkylating agent dacarbazine.Temozolomide is not directly active but undergoes rapid, spontaneous, non-enzymatic conversion at physiologic pH to the cytotoxic compound, monomethyl triazeno imidazole carboxamide (MTIC).
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age:18-75 years, male or female. 2. Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV). 3. Has not received any systematic anti-tumor drug treatment. 4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. 5. ECOG 0-1. 6. Adequate organ function. 7. Life expectancy of greater than 12 weeks. 8. Patient has given written informed consent.
Exclusion criteria
1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. 2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation. 3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ); 4. Subjects with any active autoimmune disease or history of autoimmune disease 5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 6. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); 7. Received a live vaccine within 4 weeks of the first dose of study medication. 8. Pregnancy or breast feeding. 9. Decision of unsuitableness by principal investigator or physician-in charge.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Through study uncompletion, an average of 1 year | Objective Response Rate |
Outcome results
None listed