Actively Recruiting
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
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This project intends to carry out phase I clinical studies on the basis of the previous work, initially exploring the possible effective dose, evaluating its safety and tolerability, with a view to achieving long-term control of the disease, which is expected to provide more options for the treatment of patients with advanced malignant solid tumors. The development of this project will provide new ideas, strategies and theoretical basis for the research and development of whole tumor cell vaccines; at the same time, it is expected to obtain original new drugs with independent intellectual property rights.
CONDITIONS
Official 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 histologically or cytologically, including skin or limb melanoma, head and neck tumors, and soft tissue tumors.
- Previous failure of second-line or higher treatment as per relevant clinical oncology guidelines.
- Presence of at least one measurable or evaluable lesion according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) physical status score between 0 and 2.
- Expected survival of at least 3 months.
- Good major organ function with laboratory values within specified limits for hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, creatinine, prothrombin time, and cardiac function.
- Ability to understand and voluntarily sign informed consent before the trial.
You will not qualify if you...
- History of other tumors except for cured and non-recurrent basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal carcinoma, or other malignancies deemed eligible by the investigator.
- Known uncontrolled cardiac conditions such as NYHA class II or higher heart failure, unstable angina, recent myocardial infarction within 6 months, or significant arrhythmias requiring treatment.
- Evidence or history of asthma, pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired lung function.
- Any uncontrolled clinical disease or psychiatric illness that would interfere with informed consent, trial results, or pose risks.
- Active or history of autoimmune diseases including neurological disorders, multiple sclerosis, neuropathies, Guillain-Barre Syndrome, myasthenia gravis, lupus, connective tissue diseases, inflammatory bowel disease, autoimmune hepatitis, or severe skin reactions (except stable type I diabetes).
- Allergy to the test drug or history of severe allergies to drugs, food, or vaccines.
- Contraindications for intradermal injection including injection site inflammation, trauma, ulceration, severe bleeding, or significant coagulation disorders.
- Participation in other clinical trials within 3 months before screening.
- Major surgery within 4 weeks prior to first vaccination dose or insufficient recovery from surgery or trauma.
- Unresolved adverse reactions from previous antitumor therapies above grade 1 (except alopecia).
- Use of systemic corticosteroids or immunosuppressants within 14 days before first vaccination dose (inhaled or topical steroids allowed under certain conditions).
- Known infections with hepatitis B, hepatitis C, HIV, or syphilis at screening.
- History or presence of active tuberculosis or severe infections requiring systemic therapy.
- History of substance abuse or medical, psychological, or social conditions like alcohol or drug abuse.
- Pregnant or breastfeeding women, or those planning pregnancy within 12 months after full drug course.
- Any other factors deemed inappropriate for trial participation by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan Universit
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xingchen Peng, Professor
CONTACT
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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