The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with high-risk recurrent solid tumors after radical surgery.
The main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does XH001 injection combined with standard adjuvant treatment induce a specific T-cell response, and can it prolong the patient's relapse-free survival?
Provision of signed and dated informed consent form;
Aged between 18 and 70 years old, male or female;
Patients with high-risk recurrent solid tumors confirmed by pathology after radical surgery mainly include pancreatic ductal adenocarcinoma, biliary tract malignancies, hepatocellular carcinoma, gastric adenocarcinoma, etc.
Expected survival duration ≥12 months;
There is evidence of tumor residue, recurrence or metastasis during screening;
Has a history of hepatic encephalopathy or liver transplantation;
Has clinical uncontrolled (requiring repeated drainage) pericardial effusion, pleural effusion and moderate or severe ascites;
Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (>=Grade 3) to XH001 injection and/or any of its excipients;