NCT03468244

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

March 8, 2018

Last Update Submit

February 25, 2019

Conditions

Advanced Esophageal Squamous CarcinomaGastric AdenocarcinomaPancreatic AdenocarcinomaColorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    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

    24 weeks

Secondary Outcomes (4)

  • Disease Control Rate of Personalized mRNA Tumor Vaccine

    1.5 years

  • Progression-free Survival of Personalized mRNA Tumor Vaccine

    2 years

  • Time to Tumor Progression of Personalized mRNA Tumor Vaccine

    2 years

  • Overall Survival of Personalized mRNA Tumor Vaccine

    3 years

Study Arms (1)

Personalized mRNA Tumor Vaccine

EXPERIMENTAL

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

Interventions

Personalized mRNA Tumor VaccineBIOLOGICAL

subcutaneous injection with personalized mRNA tumor vaccine at least four times

Personalized mRNA Tumor Vaccine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 - 75 with pathologically confirmed advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma.
  • 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.
  • Expected survival after first dose of study drug \> 24 weeks.
  • At least one measurable lesion (≥ 10 mm) for imaging assessment.
  • ECOG scores 0 - 1.
  • Fresh pathological tissue specimens can be obtained
  • 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%
  • Serum albumin (Alb) ≥ 30 g/L
  • Serum lipase (LPS) and serum amylase \< 1.5 ULN
  • Serum creatinine ≤ 1.5 ULN
  • +7 more criteria

You may not qualify if:

  • Patients with any of the following conditions are not eligible for the study.
  • Pregnant or lactating women.
  • HIV positive, HCV positive, HBV DNA copies ≥ 10\^3.
  • Uncontrolled active infection.
  • Allergic to immunotherapies and related drugs.
  • Untreated brain metastases or having symptoms of brain metastases.
  • Metastases to the lung: central tumor or multiple metastases.
  • Patients with heart disease for which treatment is needed or with poorly controlled hypertension.
  • Patients with unstable or active peptic ulcer or with alimentary tract hemorrhage.
  • Patients with previous organ transplantation or in preparation for organ transplantation.
  • 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.
  • The judgment of investigators that the patient is not able to or not willing to follow the instructions of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

  • Wang B, Peng X, Li J, Wang Y, Chen L, Wu M, Zhang Y, Wang W, Feng D, Tang S, Zhang L, Zhan X. Personalized mRNA vaccine combined with PD-1 inhibitor therapy in a patient with advanced esophageal squamous cell carcinoma. Am J Cancer Res. 2024 Aug 25;14(8):3896-3904. doi: 10.62347/NVFB3780. eCollection 2024.

    PMID: 39267685DERIVED

Study Officials

  • Xianbao Zhan, Dr.

    Chanhai hospital

    STUDY DIRECTOR

Central Study Contacts

Bin Wang, Dr.

CONTACT

+86 02131161448qcwangb@163.com

Xianbao Zhan, Dr.

CONTACT

+86 02131161441zhanxianbao@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 16, 2018

Study Start

May 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2021

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

CN(1)