NCT07594964 To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors
| NCT ID | NCT07594964 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shenzhen Xinhe Biomedical |
| Condition | Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2029-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2025-08-25 with a primary completion date of 2029-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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?
Eligibility Criteria
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07594964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07594964 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07594964 currently recruiting?
Yes, NCT07594964 is actively recruiting participants. Contact the research team at yiz@neocura.net for enrollment information.
Where is the NCT07594964 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT07594964 clinical trial?
NCT07594964 is sponsored by Shenzhen Xinhe Biomedical. The trial plans to enroll 48 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.