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

May 18, 2026 updated by: Shenzhen Xinhe Biomedical

Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors After Radical Surgery

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Lin Shen, Prof.
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Wenmin Wu, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
XH001 injection administered based on adjuvant chemotherapy with the mFOLFIRINOX regimen
Biological: XH001 Injection
mRNA neoantigen cancer vaccine
Drug: mFOLFIRINOX Treatment Regimen
oxaliplatin+lrinotecan+calcium folinate+5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event
Time Frame: up to 36 months
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
Time Frame: From the first administration of XH001 to 4 weeks after the first administration of XH001 injection.
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
Time Frame: From Baseline up to 2 years.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent-Free Survival
Time Frame: 3 years
The time from the patient undergoing radical surgery to recurrence or death from any cause, whichever comes first.
3 years
Local Recurrent-Free Survival
Time Frame: 3 years
The time from the patient undergoing radical surgery to local recurrence or death from any cause, whichever comes first.
3 years
Distant metastasis-Free Survival
Time Frame: 3 years
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.
3 years
Overall survival
Time Frame: 3 years
The time from the patient undergoing radical surgery to death from any cause.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Xinhe Biomedical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2025

Primary Completion (Estimated)

October 30, 2029

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH001-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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