NCT05749627

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

February 19, 2023

Last Update Submit

February 25, 2025

Conditions

Advanced Malignant Solid Tumors

Keywords

Neoantigen Peptide VaccineNeoantigen-based Dendritic CellsTherapeutic immune preparationAdvanced Malignant Solid TumorsProgression-free SurvivalOverall SurvivalOverall Response Rate

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (5)

  • Overall survival

    9 months after treatment

  • Disease control rate

    1 week after treatment

  • Tumor imaging

    9 months after treatment

  • Peripheral blood cytokines

    9 months after treatment

  • ECOG

    9 months after treatment

Study Arms (1)

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.

Drug: Neoantigen peptide vaccineDrug: Neoantigen-based DC immune preparation

Interventions

Neoantigen peptide vaccineDRUG

Personalized tumor neoantigen peptide vaccine

Neoantigen peptide vaccine/neoantigen-based DC treatment
Neoantigen-based DC immune preparationDRUG

Personalized tumor neoantigen DC therapeutic immune preparation

Neoantigen peptide vaccine/neoantigen-based DC treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung cancer, etc.
  • Failed in standard treatment or voluntarily give up other treatment, and been longer than 2 weeks from the end of the last anti-tumor treatment
  • Had disease progression prior to treatment
  • Expected survival ≥ 3 months
  • ECOG performance status of 0, 1, or 2
  • With a negative pregnancy test for females of childbearing age
  • Able to take effective contraceptive measures and ensure that there is no birth plan within half a year of the study
  • Not positive for HIV, HBV, HCV, or TP
  • ALT/AST ≤ 2.5 times the upper limit of normal
  • ALP ≤ 2.5 times the upper limit of normal
  • Serum creatinine ≤1.6 mg/dL
  • Total bilirubin ≤ 1.5 mg/dL
  • In the absence of granulocyte colony-stimulating factor support, proportion of lymphocytes \> 20%, absolute neutrophil count ≥ 1x10\^9/L, white blood cell count ≥ 3x10\^9/L, platelet count ≥ 100×10\^9/L, hemoglobin \> 8.0 g/dL, CD4+ cell count \> 200/μL
  • With normal coagulation test and ECG
  • Able to understand and willing to sign a written informed consent form

You may not qualify if:

  • Pregnant or breastfeeding women
  • Patients with brain metastases
  • Had immunosuppressant therapy within 1 month or received other immunotherapy within 3 months
  • Participated in other clinical study within 30 days
  • With severe allergies or histories of severe allergy
  • With splenectomy
  • With primary or secondary immunodeficiency diseases or autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, psoriasis, uncontrolled asthma, etc.)
  • Had oral, intramuscular, or intravenous corticosteroids within 1 month. However, inhaled corticosteroids are allowed to treat respiratory insufficiency (such as chronic obstructive pulmonary disease), as well as topical steroids
  • With uncontrollable epilepsy, central nervous system disorder, or neurological disease with loss of cognitive ability
  • With a history of chronic alcohol or drug abuse within 6 months
  • With unstable systemic diseases (including active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina, congestive heart failure, myocardial infarction within 1 year, etc.)
  • With a history of other malignant tumors in the past 5 years (excluding those who have been clinically cured, and squamous cell carcinoma or skin basal cell carcinoma)
  • Those the researcher believed inappropriate to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Central Study Contacts

Sujun Li, PhD

CONTACT

861760069982617600699826@163.com

Aiping Le

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 1, 2023

Study Start

April 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations

CN(1)