Cancer research in India: Challenges & opportunities
Inclusion Criteria:
age:18-75 years, male or female.
Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
Has not received any systematic anti-tumor drug treatment.
Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
ECOG 0-1.
Adequate organ function.
Life expectancy of greater than 12 weeks.
Patient has given written informed consent.
Exclusion Criteria:
Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
Subjects with any active autoimmune disease or history of autoimmune disease
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;
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);
Received a live vaccine within 4 weeks of the first dose of study medication.
Pregnancy or breast feeding.
Decision of unsuitableness by principal investigator or physician-in charge.