Study design and patients
NSCLC, HCC, HNC, Tumors
COLORECTAL CANCER, RECURRENCE, METASTASIS, BRAIN METASTASES, SOLID TUMORS, TUMORS, PANCREATIC CANCER, NSCLC, ONCOLOGY, GASTRIC CANCER
This was a single-arm, multicenter, open-label, phase II study (NCT04569916). The main center of the clinical trial was Nanjing Drum Tower Hospital affiliated to Nanjing University Medical School, and sub-centers were Affiliated Hospital of Jiangsu University and Huai’an Second People’s Hospital. This study was approved by the ethics committees of the above three hospitals. Patients provided written informed consent.Eligible patients were aged 18 years or older, pathologically confirmed with recurrence or metastasis solid tumors (such as pancreatic cancer, colorectal cancer, NSCLC, HCC, HNC, gastric cancer, etc.). Patients have progressed on or lacked systemic therapy. Other key inclusion criteria included at least two measurable lesions (at least one extracranial measurable lesion for patients with brain metastases) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2, a life expectancy of at least 12 weeks and had adequate organ function. The complete list of eligibility criteria is provided in 