Actively Recruiting
Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer
Led by Beijing GoBroad Hospital · Updated on 2026-02-12
18
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
N
NeoCura
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastrointestinal cancer in adults. It will also learn if the combined treatment works to treat advanced gastrointestinal cancer.The main questions it aims to answer are:What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?
CONDITIONS
Official Title
Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Age between 18 and 70 years, male or female
- Diagnosed advanced gastrointestinal cancer confirmed by pathology
- Disease failed to respond to second-line standard treatment, is intolerant, or unsuitable for standard treatment
- At least one measurable tumor lesion per RECIST 1.1, with total tumor diameter 100mm and single lesion diameter 30mm
- If local treatment was given to the only lesion, must show clear imaging evidence of disease progression
- Expected survival of 12 weeks or more
- Adequate organ and bone marrow function
You will not qualify if you...
- Need for long-term systemic antiallergic drugs or severe hypersensitivity to XH001 or its components (Grade 3)
- Symptomatic central nervous system or meningeal metastases
- Immunomodulatory drug therapy within 2 weeks before first XH001 dose
- Skin diseases preventing intradermal injection (e.g., psoriasis)
- Unresolved toxic side effects from previous treatments above CTCAE grade 2, except hair loss
- Systemic steroid use exceeding 10mg prednisone daily or other immunosuppressive treatment within 7 days before first XH001 dose, except specified local steroid uses
- Prior therapeutic tumor vaccines or cell therapy products
- Previous allogeneic stem cell or bone marrow transplant, solid organ transplant, or current immunosuppressive drug use
- Active or poorly controlled severe infections
- Positive for HIV antibodies, high hepatitis B virus DNA, hepatitis C antibodies, or Treponema pallidum antibodies
- Other malignancies within 5 years except certain cured forms
- History of autoimmune diseases
- Active pulmonary tuberculosis
- Systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, hormone therapy, or unapproved trial drugs/instruments within 2 weeks before screening
- Participation in other clinical trials during screening
- Pregnant or lactating women
- Other severe medical or psychiatric conditions or lab abnormalities that increase risk or interfere with trial results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Gobroad Hospital
Beijing, China
Actively Recruiting
Research Team
C
Changsong Qi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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