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

NCT07594964 | Recruiting Phase 1

• 1 other identifier: XH001-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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?

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC); Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer); Hepatocellular Carcinoma (HCC); Gastric Cancer (GC)

Keywords

mRNA; Neoantigen specific tumor vaccine

Outcome Measures

Primary Outcomes (3)

• 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)

  up to 36 months

• Dose-Limiting Toxicity

  Grade 3 or higher adverse events (AEs) or laboratory abnormalities related to XH001 injection

  From the first administration of XH001 to 4 weeks after the first administration of 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.

  From Baseline up to 2 years.

Secondary Outcomes (4)

• Recurrent-Free Survival

  3 years

• Local Recurrent-Free Survival

  3 years

• Distant metastasis-Free Survival

  3 years

• Overall survival

  3 years

Study Arms (1)

Treatment

EXPERIMENTAL

XH001 injection administered based on adjuvant chemotherapy with the mFOLFIRINOX regimen

Biological: XH001 Injection; Drug: mFOLFIRINOX Treatment Regimen

Interventions

XH001 Injection BIOLOGICAL

mRNA neoantigen cancer vaccine

Treatment

mFOLFIRINOX Treatment Regimen DRUG

oxaliplatin+lrinotecan+calcium folinate+5-FU

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen Xinhe Biomedical: lead

Study Sites (2)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Peking University Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms; Carcinoma, Hepatocellular; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Gallbladder Diseases; Liver Neoplasms; Liver Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Yi Zhang

CONTACT

0086-18615536063; yiz@neocura.net

Bo Liu

CONTACT

0086-18101388626; bliu@neocura.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start: August 25, 2025
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

CN (2)