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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Polyphenol whole tumor cell vaccine
Biological/Vaccine3 patients enrolled in each dose group, and planned dose groups of 5 x 10\*6, 2 x 10\*7, and 5 x 10\*7 cells/dose. The dosing regimen consisted of 5 doses of basal immunization and subsequent individualized treatment. In the basal immunization, the administration times were D0, D14, D28, D42, and D56. After completion of the 5 doses of basal immunization, the subsequent individualized treatment was decided by the investigator based on the subject's tumor assessment, i.e., 1 vaccination per month for a total of 4 doses.
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: Polyphenol whole tumor cell vaccineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability.
DLT was defined as a therapeutic drug-related TEAE or clinically significant abnormal laboratory test occurring during the DLT observation period as follows:1) Hematologic toxicity:① ≥ grade 4 neutropenia lasting more than 5 days (after symptomatic treatment);② ≥ grade 3 febrile neutropenia;③ ≥ grade 4 thrombocytopenia;④ ≥ grade 3 thrombocytopenia with bleeding tendency;⑤ ≥ grade 4 anemia.2) Non-hematological toxicity:① ≥ grade 3 non-hematologic toxicity shall be considered DLT, except for the following:a) Alopecia of any grade;b) Grade 3 nausea, vomiting, or diarrhea, if well controlled within 72 hours;c) Grade 3 fatigue \< 7 days;d) Abnormal laboratory tests without clinically relevant signs or symptoms.② Any concurrent grade ≥2 total bilirubin elevation and grade ≥3 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (Hay's rule); for patients with liver metastases, an AST or ALT \> 8 x upper limit of normal (ULN); and an AST or ALT \> 5 x ULN for ≥14 days.
Time frame
From the time of the first dose to 14 days after the last vaccination.Secondary outcomes
1
Objective Response Rate(ORR)
It refers to the proportion of patients whose tumors have shrunk to a certain extent and remained so for a certain period of time. It is a direct indicator to measure the anti-tumor activity of drugs.It is usually calculated as the percentage of the sum of the number of patients with complete response (CR) and partial response (PR) in the total number of patients.
Time frame
From the time when the patients were enrolled in the study to the whole study completion, an average of 1 year.2
Progression-free survival (PFS).
PFS was defined as the time interval from the initiation of study treatment to the first occurrence of PD or death due to any cause.
Time frame
From the time when the patients were enrolled in the study to the whole study completion, an average of 1 year.3
Overall survival (OS).
OS was defined as the time interval from the start of study treatment to the death of the subject.
Time frame
From the time when the patients were enrolled in the study to the whole study completion, an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xingchen Peng
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov