Procedures
toxicity, liver and kidney function, electrolytes coagulation, tumor
DISEASE PROGRESSION, TUMOR
Gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) were administered to the patients on days 1 and 8, respectively, per 21-day cycle, with a total of 6–8 cycles of chemotherapy. Sintilimab (200 mg) was intravenously administered on day 1 of each 21-day cycle. This combination regimen was sustained until disease progression, intolerable toxicity, or completion of 6–8 cycles of the treatment. The maintenance treatment with sintilimab was administered for 2 years to patients who completed 6–8 cycles (determined by the treating physician and the patient) of the combination therapy. During this treatment period, any kind of dose modification of sintilimab was not allowed.Patients could withdraw from this trial at any point without disrupting their standard therapy or harming their chances of potential participation in other research studies. Investigators could terminate the participation of patients if they had reason to believe that further treatment would be harmful to their well-being. Patients accepted evaluation of efficacy per 6 weeks, examination of blood routine, liver and kidney function, levels of serum electrolytes coagulation, tumor indicators, and immune-related indicators were reviewed simultaneously. Furthermore, they were evaluated for safety profiles during each visit. Detailed study protocol and statistical analysis plan were provided in the supplementary materials.