a Polyphenol Whole Tumor Cell Vaccine in Patients With Advanced Malignant Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXingchen Peng

About this trial

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.

Eligibility criteria

Qualifiers

Male or female patients aged 18 to 65 years (including borderline values) at screening.

Advanced metastatic malignant solid tumors (skin or limb melanoma/head and neck tumors/soft tissue tumors, etc.) confirmed histologically or cytologically, with previous failure of second-line or higher treatment (refer to the China Clinical Oncology (CSCO) Melanoma Guidelines 2024, CSCO Head and Neck Tumor Guidelines 2024, and CSCO Bone and Soft Tissue Tumor Guidelines.

Presence of at least 1 measurable or evaluable lesion according to RECIST v1.1 criteria.

Eastern Cooperative Oncology Group (ECOG) physical status score: 0 to 2.

Disqualifiers

Patients with a prior 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, and other histories of malignancies deemed by the investigator to be eligible for enrollment.

Patients with known concomitant cardiac clinical conditions or diseases that are not well controlled, e.g., New York Heart Association (NYHA) class II or higher heart failure (see 16.5 Appendix V), unstable angina, myocardial infarction within 6 months, supraventricular or ventricular arrhythmias that are clinically significant and require treatment or intervention.

Patients with previous and current objective evidence of asthma, history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severely impaired lung function.

Have any uncontrollable clinical disease (e.g., respiratory, circulatory, digestive, neurologic, hematologic, genitourinary, endocrine system disorders) or psychiatric disease (e.g., depression, schizophrenia) or other significant illnesses assessed by the investigator as preventing the provision of informed consent, interfering with the interpretation of the trial results, potentially posing a risk to subjects by participating in this trial, or otherwise otherwise interfere with achieving the purpose of the study.

Trial design

Treatments tested in this trial

  • Polyphenol whole tumor cell vaccine

Treatment groups

9 Participants
are divided into 1 treatment group

Sponsors and collaborators

Xingchen Peng

Lead sponsor

West China Hospital

Sponsor institution