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;
Single group
XH001 Injection
Biological/VaccinemRNA neoantigen cancer vaccine
mFOLFIRINOX Treatment Regimen
Drugoxaliplatin+lrinotecan+calcium folinate+5-FU
Adverse Event
Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (based on the Criteria for the Evaluation of Adverse Events \[CTCAE\] v5.0)
Dose-Limiting Toxicity
Grade 3 or higher adverse events (AEs) or laboratory abnormalities related to XH001 injection
Immune response at different doses
Using in vitro ELISPOT and/or TCR-Clone track to verify the immunoreactivity of the peripheral blood lymphocytes from the subjects to the selected tumor neoantigens.
Recurrent-Free Survival
The time from the patient undergoing radical surgery to recurrence or death from any cause, whichever comes first.
Local Recurrent-Free Survival
The time from the patient undergoing radical surgery to local recurrence or death from any cause, whichever comes first.
Distant metastasis-Free Survival
The time from the patient undergoing radical surgery to distant metastasis or death from any cause, whichever comes first. If the patient has not developed metastasis by the end of the study, the last follow-up time will be the endpoint.
Overall survival
The time from the patient undergoing radical surgery to death from any cause.
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