To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors

Inclusion criteria

• 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;
• ECOG score of 0-1;
• White blood cell count≥ 3.0×10^9/L; Neutrophil count ≥ 1.0×10^9/L; Platelet count ≥75×10^9/L; Hemoglobin (Hb)≥ 90g/L; Creatinine clearance rate≥50mL/min [calculated using the Cockcroft-Gault formula]; Alanine aminotransferase ≤ 3×ULN (patients with hepatocellular carcinoma or biliary tract malignancy <5×ULN); Aspartate aminotransferase ≤ 3×ULN ((patients with hepatocellular carcinoma or biliary tract malignancy <5×ULN); Total bilirubin ≤ 3×ULN; Serum albumin > 28g/L; Coagulation: Prothrombin time prolongation ≤ 4s;

Exclusion criteria

• 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;
• New cerebrovascular accidents within 6 months before screening (including ischemic stroke, hemorrhagic stroke and transient ischemic attack)；
• Individuals who have experienced acute myocardial infarction, or have uncontrolled angina pectoris, uncontrolled arrhythmia, severe heart failure (NYHA heart failure classification standard>= Grade III) and other cardiovascular diseases within 6 months before screening;
• Patients with pancreatic ductal adenocarcinoma (PDAC) have the following conditions: 1) Borderline resectable pancreatic ductal adenocarcinoma; 2) Tumor tissue containing neuroendocrine tumor components (i.e., mixed type); 3) Pancreatic tumor types other than PDAC; 4) Persistent severe diarrhea after surgery;
• Patients with biliary tract malignancy have the following conditions: 1) Pancreatic or ampullary cancer; 2) Unresolved biliary obstruction; 3) Insufficient surgical biliary drainage, and there are signs of infection;
• .Subjects with hepatocellular carcinoma exhibit the following conditions: 1) The tumor contains components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and biliary tract malignancy; 2) Received more than one cycle of adjuvant TACE after surgery or ablation;
• Patients with gastric adenocarcinoma have the following conditions: severe postoperative complications (severe postoperative infection, anastomotic leakage and gastrointestinal bleeding);
• Have active or poorly controlled severe infections;
• .Patients with other malignancies within 5 years before enrollment, except for those with a history of appropriately treated and cured cervical carcinoma in situ, breast carcinoma in situ, or skin basal cell carcinoma;
• Any history of autoimmune diseases (regardless of whether they are currently active),；
• Who have previously received similar therapeutic tumor vaccines;