Custom mRNA vaccine aims to stop Cancer's return after surgery
NCT ID NCT07594964
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a personalized mRNA cancer vaccine (XH001) given alongside standard treatment after surgery for people with high-risk solid tumors (bile duct, gallbladder, pancreatic, liver, or stomach cancer). The main goals are to check safety and see if the vaccine can trigger the immune system to fight remaining cancer cells, potentially delaying or preventing the cancer from coming back. About 48 participants will be enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
RECRUITINGBeijing, China
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Peking University Cancer Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Zapping liver tumors to make them operable
- Triple drug combo targets advanced liver cancer in new trial
- Triple attack on pancreatic tumors: can radiation and immunotherapy make inoperable cancer operable?
- One small incision vs several: robotic stomach cancer surgery put to the test
- Old antiparasitic drug joins chemo in pancreatic cancer fight
- Can PET scans reveal which stomach cancers will respond to immunotherapy?