Personalized mRNA tumor vaccine plus standard therapy for high-risk recurrent solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human trial explores the safety and preliminary efficacy of XH001 Injection, a personalized mRNA tumor neoantigen vaccine, when given with standard adjuvant therapy in adults who have high-risk recurrent solid tumors after complete surgical removal. Participants receive XH001 alongside a chemotherapy regimen (mFOLFIRINOX) to potentially stimulate a targeted T-cell response against tumor-specific neoantigens. The study aims to determine safety and whether the combination can induce an specific immune response and prolong relapse-free survival. Enrollment focuses on biliary cancers, pancreatic ductal adenocarcinoma, hepatocellular carcinoma, and gastric cancer, with eligibility requiring adequate organ function and performance status. This phase 1 trial is conducted at major Beijing institutions, led by Shenzhen Xinhe Biomedical.

Why it matters

Who can join: the full rules

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;

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting
• Peking University Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yi Zhang
• Email: yiz@neocura.net
• Phone: 0086-18615536063

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.