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Trial record 67 of 6674 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03468244
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Stemirna Therapeutics
Information provided by (Responsible Party):
Bin Wang, Changhai Hospital

Brief Summary:
A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma

Condition or disease Intervention/treatment Phase
Advanced Esophageal Squamous Carcinoma Gastric Adenocarcinoma Pancreatic Adenocarcinoma Colorectal Adenocarcinoma Biological: Personalized mRNA Tumor Vaccine Not Applicable

Detailed Description:

Dr. Bin Wang developed the investigational vaccine used in this clinical trial and designed the trial protocol.For patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma tumor who have disease progression with first line chemotherapy. Single or multiple doses of personalized mRNA tumor vaccine encoding neoantigen will be given to observe the safety and efficacy the mRNA tumor vaccine.

Primary objectives:

Determine the safety, tolerability and cytokinetics of the personalized mRNA tumor vaccine in patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma.

Secondary objectives:

Make a preliminary evaluation on the efficacy of personalized mRNA tumor vaccine in patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma with the following parameters:

Time of tumor progression (TTP);

Disease Control Rate (DCR);

Objective Remission Rate (ORR);

Overall Survival (OS).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Personalized mRNA Tumor Vaccine
Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients with Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma
Biological: Personalized mRNA Tumor Vaccine
subcutaneous injection with personalized mRNA tumor vaccine at least four times




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 weeks ]

    During the trial conduction, especially within the 24 weeks of treatment phase when mRNA tumor Vaccine administered, all adverse events (including laboratory abnormality and clinical events) will be closely monitored, and all ≥ grade 3 adverse events per CTCAE (v 3.0) will be recorded, including but not limited to the toxicities potentially suspected to relate to injection procedures and/or mRNA Tumor Vaccine therapy as listed below:

    • Fever
    • Chills
    • Nausea, vomiting and other gastrointestinal symptoms
    • Fatigue
    • Hypotension
    • Respiratory distress
    • Tumor lysis syndrome
    • Neutropenia, thrombocytopenia
    • Liver and kidney dysfunction


Secondary Outcome Measures :
  1. Disease Control Rate of Personalized mRNA Tumor Vaccine [ Time Frame: 1.5 years ]
    Disease Control Rate (DCR)

  2. Progression-free Survival of Personalized mRNA Tumor Vaccine [ Time Frame: 2 years ]
    Progression-free Survival (PFS)

  3. Time to Tumor Progression of Personalized mRNA Tumor Vaccine [ Time Frame: 2 years ]
    Time to Tumor Progression (TTP)

  4. Overall Survival of Personalized mRNA Tumor Vaccine [ Time Frame: 3 years ]
    Overall Survival (OS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 - 75 with pathologically confirmed advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma.
  2. Patients with advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma who have disease progression with first line chemotherapy. (1) Failure of treatment is defined as disease progression, recurrence or metastatic disease, or intolerable toxicities occurred after treatment. (2) Each line of treatment during the period of disease progression includes one or more chemotherapy drugs which are administered for not less than one cycle or even longer. Neoadjuvant/adjuvant therapy can be applied at an earlier stage of treatment. If patient has developed recurrence or metastatic disease within 24 weeks of neoadjuvant/adjuvant therapy, it is considered as one line of systemic chemotherapy. (3) Therapies that can be performed at an earlier stage are chemotherapy in conjunction with molecular targeted drugs.
  3. Expected survival after first dose of study drug > 24 weeks.
  4. At least one measurable lesion (≥ 10 mm) for imaging assessment.
  5. ECOG scores 0 - 1.
  6. Fresh pathological tissue specimens can be obtained
  7. White blood cells (WBCs) ≥ 2.5×10^9/L

    • Platelets (PLT) ≥ 100×10^9/L
    • Hemoglobin, Blood (Hb) ≥ 9.0 g/dL
    • MID ≥ 1.5×10^9/L
    • Lymphocyte (LY) ≥ 0.47×10^9/L
    • LY% ≥ 15%
  8. Serum albumin (Alb) ≥ 30 g/L
  9. Serum lipase (LPS) and serum amylase < 1.5 ULN
  10. Serum creatinine ≤ 1.5 ULN
  11. Alanine aminotransferase (ALT) ≤ 2.5 ULN

    • Aspartate aminotransferase (AST) ≤ 2.5 ULN
    • If osseous metastasis or liver metastasis is developed and alkaline phosphatase • (ALP) > 2.5 ULN, ALT and AST < 1.5 ULN.
  12. Serum total bilirubin (TBIL) ≤ 1.5 ULN
  13. Prothrombin Time (PT): International Normalized Ratio (INR) < 1.7.

    • PT < (ULN + 4) s

All test results should be within their normal ranges, and the patient is not receiving continuous supportive care.

Exclusion Criteria:

Patients with any of the following conditions are not eligible for the study.

  1. Pregnant or lactating women.
  2. HIV positive, HCV positive, HBV DNA copies ≥ 10^3.
  3. Uncontrolled active infection.
  4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  5. Allergic to immunotherapies and related drugs.
  6. Untreated brain metastases or having symptoms of brain metastases.
  7. Metastases to the lung: central tumor or multiple metastases.
  8. Patients with heart disease for which treatment is needed or with poorly controlled hypertension.
  9. Patients with unstable or active peptic ulcer or with alimentary tract hemorrhage.
  10. Patients with previous organ transplantation or in preparation for organ transplantation.
  11. Patients have undertaken major surgeries or have been badly injured 4 weeks before the study (blood collection), or will undertake major surgeries during the study.
  12. The judgment of investigators that the patient is not able to or not willing to follow the instructions of the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468244


Contacts
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Contact: Bin Wang, Dr. +86 02131161448 qcwangb@163.com
Contact: Xianbao Zhan, Dr. +86 02131161441 zhanxianbao@126.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China
Contact: Bin Wang, Dr.    +86 01231161448    qcwangb@163.com   
Contact: Xianbao Zhan, Dr.    +86 01231161441    Zhanxianbao@126.com   
Principal Investigator: Xianbao Zhan, Dr.         
Sub-Investigator: Bin Wang, Dr.         
Sponsors and Collaborators
Changhai Hospital
Stemirna Therapeutics
Investigators
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Study Director: Xianbao Zhan, Dr. Chanhai hospital

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Responsible Party: Bin Wang, Attending physician, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03468244     History of Changes
Other Study ID Numbers: CHO-01002
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Vaccines
Immunologic Factors
Physiological Effects of Drugs