Procedures
tumor, nausea, Tumor, fatigue, fever, telangiectasia, headache, epistaxis, deaths, chills, Cancer
DISEASE PROGRESSION, TUMOR, ADVERSE EVENT, TUMOR, ADVERSE EVENT, EPISTAXIS, APPENDIX, CANCER
Dose de-escalation phase. The primary objective of this phase was to evaluate the safety and the RP2D of GT90001 combined with nivolumab. A rolling-six design was used (Appendix File Dose-expansion phase. The primary objective of this phase was to assess the efficacy and safety of GT90001 at the recommended dosage in combination with nivolumab. After the RP2D was determined, additional patients were enrolled in the dose-expansion cohort (Appendix File Tumor response was evaluated by investigators according to RECIST 1.1. Assessments of tumor response were conducted by computed tomography (CT) or magnetic resonance imaging at baseline and scheduled for every 8 weeks within one year, then every 12 weeks thereafter (with a window of ± 1 week) until disease progression. Confirmation of partial response (PR) or complete response (CR) is required at 4 weeks after response, as per RECIST 1.1 [Safety and tolerability were monitored throughout the trial and during the 30-day follow-up period (after the last administration of the study treatment). Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) and incidence of any TEAEs, serious AEs (SAEs), treatment-related AEs, AEs leading to discontinuation, and deaths, were recorded. The following AEs were considered related to the mechanism of action of GT90001, including platelet count decreased, fatigue, fever, telangiectasia, amylase increased, lipase increased, epistaxis, nausea, chills, and headache. Patients were monitored by physical examination, chest radiography, ECOG performance score, vital signs, and laboratory analyses (hematology, serum biochemistry, urinalysis, and coagulation) at baseline, before cycles 1–3, every 8 weeks within one year, every 12 weeks thereafter, at the end of study treatment, and follow-up 30 days.