Actively Recruiting
A Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of a Polyphenol Whole Tumor Cell Vaccine in Patients With Advanced Malignant Solid Tumors
Led by Xingchen Peng · Updated on 2025-06-05
9
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase I clinical trial to explore a new type of cancer vaccine called the polyphenol whole tumor cell vaccine for patients with advanced malignant solid tumors. These tumors include cancers originating in epithelial, mesenchymal, or nervous tissues. The study aims to find the effective dose, assess safety and tolerability, and ultimately provide new treatment options to help control the disease long-term. This vaccine is based on previous promising research that showed enhanced immune responses and tumor suppression in animal models. The trial involves administering the polyphenol whole tumor cell vaccine at different dose levels to small groups of patients using a "3+3" dose escalation design. Patients receive five doses of basal immunization on days 0, 14, 28, 42, and 56, followed by individualized treatments of one dose per month for four months, depending on tumor assessment. The vaccine includes tumor cells coated with plant polyphenols and uses bacterial lipopolysaccharide as an adjuvant to stimulate the immune system against multiple tumor antigens. Participants will be closely monitored throughout the study for safety and side effects from the first dose until 14 days after the last vaccination. Researchers will also evaluate tumor response, progression-free survival, and overall survival over about one year. The study includes thorough assessments of organ function, blood tests, and tumor measurements. The trial is expected to last until the end of 2026 and aims to provide important information on the vaccine's safety and preliminary anti-tumor activity in patients with advanced solid tumors.
CONDITIONS
Brief Title
a Polyphenol Whole Tumor Cell Vaccine in Patients With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 65 years (including borderline values) at screening.
- Advanced metastatic malignant solid tumors confirmed by histology or cytology, having failed second-line or higher treatments.
- At least one measurable or evaluable tumor lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Expected survival time of at least 3 months.
- Good function of major organs with specific blood and organ function test results within 7 days prior to treatment.
- Able to understand and voluntarily sign written informed consent before the trial.
You will not qualify if you...
- History of other tumors except certain cured or non-recurrent cancers deemed eligible by the investigator.
- Known uncontrolled cardiac conditions or diseases such as NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias.
- History or evidence of asthma, pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired lung function.
- Uncontrollable clinical or psychiatric diseases that prevent informed consent or pose risks.
- Active autoimmune diseases or history of autoimmune disorders including neurological and connective tissue diseases.
- Allergy to the vaccine or any related ingredients, or history of severe allergic reactions.
- Contraindications to intradermal injection such as injection site inflammation, trauma, severe bleeding, or body art at the vaccination site.
- Participation in other drug or device clinical trials within 3 months prior to screening.
- Major surgery within 4 weeks prior to first vaccination or radiotherapy and other specified treatments.
- Unrecovered adverse reactions from previous antitumor therapy above grade 1 (except alopecia).
- Use of systemic corticosteroids or immunosuppressive agents above specified doses within 14 days prior to vaccination.
- Known infections with hepatitis B, hepatitis C, HIV, or syphilis as defined by screening tests.
- History of active tuberculosis or severe acute or chronic infections needing systemic therapy.
- History of substance abuse or medical, psychological, or social conditions such as alcohol or drug abuse.
- Pregnant or breastfeeding women or those planning pregnancy within 12 months after full course.
- Any other factors judged by the investigator to make participation inappropriate.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months for basal immunization plus up to 4 additional monthly doses for individualized treatment
Participants receive a polyphenol whole tumor cell vaccine through a basal immunization of 5 doses followed by individualized treatment based on tumor assessment.
5 visits during basal immunization and up to 4 monthly visits for individualized treatment
Duration - Up to 1 year after enrollment
Participants are monitored for safety, tolerability, and antitumor activity for up to 14 days after the last vaccination and for approximately 1 year after enrollment.
Regular follow-up visits during the year after treatment completion
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan Universit
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xingchen Peng, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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