Cancer combo trial halted early: what we learned

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female aged 18-70 years; * Phase I dose escalation: Advanced gastric cancer, esophageal cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer (other than pancreatic neuroendocrine tumors) and intrahepatic cholangiocarcinoma that failed standard treatments confirmed by histopathology and/or cytology; Among them, the Child-Pugh score of liver function in patients with hepatocellular carcinoma is less than 5, * Phase II advanced hepatocellular carcinoma Dose expansion: Patients with advanced hepatocellular carcinoma who are clinically diagnosed or confirmed by histopathology and/or cytology and are not suitable for surgical resection; The patient has not undergone first-line systemic treatment \[small molecule targeted drugs (such as sorafenib, lenvatinib, etc.), systemic chemotherapy\] and tumor immunotherapy (anti-PD-1/L1, CTLA-4, etc.); Child-Pugh score of liver function ≤ 6; * Has at least one measurable lesion based on RECIST 1.1; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * Life expectancy ≥12 weeks; * Patients must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.); * History of interstitial lung disease or non-infectious pneumonia; * Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy; * Has received vaccination within 4 weeks prior to the first dose. * Has participated in other anticancer drug clinical trials within 4 weeks. * According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.