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| Name | Class |
|---|---|
| Shanghai Dengding BioAI Co. | UNKNOWN |
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In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.
This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
20 patients with primary or metastatic melanoma, gastrointestinal tumor, breast cancer, cervical cancer, pancreatic cancer, lung cancer, or other malignant tumors will be recruited in this study. With doctor's assessment, a personalized tumor neoantigen peptide vaccine or neoantigen-based DC treatment plan will be designed for each participant:
Participants will receive 5-6 subcutaneous injections of the vaccine or DC preparation within a treatment period of 14 weeks. After treatment, participants will have 3 follow-up visits during 9-months. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoantigen peptide vaccine/neoantigen-based DC treatment | Experimental | Patients assigned to the neoantigen peptide vaccine/neoantigen-based DC treatment group will receive 5-6 subcutaneous injections of neoantigen peptide vaccine or neoantigen-based DC immune preparation within a 14-week treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen peptide vaccine | Drug | Personalized tumor neoantigen peptide vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival (PFS) is the time from the inoculation of the individualized neoantigen immune preparation to disease progression or death from various causes for all patients. Tumor assessment is performed according to the RECIST1.1 standard. The analysis of this indicator includes results of tumor assessments performed during the treatment period and the follow-up period. If a patient has several indicators that can be judged as disease progression (PD), the indicator that appears first will be used for PFS analysis. Relapse, new tumors, or death are considered to have reached the end of the study. For patients who had not experienced disease progression at the end of the study, the last time the patient had no disease progression was used as censoring data. | 9 months after treatment |
| Overall response rate | Overall response rate is the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including complete response (CR) and partial response (PR) cases. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the objective response of tumors. Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation is divided into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). | 1 week after treatment |
| Tumor makers | CEA,CA19-9,CA125 | 9 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is the time from inoculation of the individualized neoantigen immune preparation to death due to various causes for all patients. | 9 months after treatment |
| Disease control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujun Li, PhD | Contact | 8617600699826 | 17600699826@163.com | |
| Aiping Le | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| Neoantigen-based DC immune preparation | Drug | Personalized tumor neoantigen DC therapeutic immune preparation |
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Disease control rate is the percentage of patients who have a complete response (CR), partial response (PR), and stable disease (SD) to the treatment.
| 1 week after treatment |
| Tumor imaging | CT/MRI scan, X-ray examination etc. | 9 months after treatment |
| Peripheral blood cytokines | Changes in peripheral blood cytokines after treatment, including IFN-γ, TNF, IL-2, etc. | 9 months after treatment |
| ECOG | Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. This scale describes patients' level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Researchers worldwide consider the ECOG Performance Status Scale when planning cancer clinical trials to study new treatments. There are 6 grades in ECOG, the minimum value is 0 and the maximum value is 5, while a higher score indicates a worse condition. | 9 months after treatment |