Advanced Esophageal Squamous CarcinomaNCT03468244
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms
A study testing Personalized mRNA Tumor Vaccine in people with Advanced Esophageal Squamous Carcinoma and Gastric Adenocarcinoma, run by Changhai Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma
- What is being tested?
- Personalized mRNA Tumor Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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.
- Serum total bilirubin (TBIL) ≤ 1.5 ULN
- 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.
Who cannot join
- 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.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Allergic to immunotherapies and related drugs.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality
Bin Wang, Dr., +86 01231161448, qcwangb@163.com
Xianbao Zhan, Dr., +86 01231161441, Zhanxianbao@126.com
About this study
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
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
Read the 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).
- Conditions
- Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Colorectal Adenocarcinoma
- Being tested
- Personalized mRNA Tumor Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized mRNA Tumor VaccineBiological
subcutaneous injection with personalized mRNA tumor vaccine at least four times
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Personalized mRNA Tumor Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (4)
Disease Control Rate of Personalized mRNA Tumor Vaccine
Disease Control Rate (DCR)
Measured: 1.5 years
Progression-free Survival of Personalized mRNA Tumor Vaccine
Progression-free Survival (PFS)
Measured: 2 years
Time to Tumor Progression of Personalized mRNA Tumor Vaccine
Time to Tumor Progression (TTP)
Measured: 2 years
Overall Survival of Personalized mRNA Tumor Vaccine
Overall Survival (OS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 May 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Esophageal Squamous CarcinomaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stemirna Therapeutics
- Responsible party
- Principal investigator, Bin Wang, Changhai Hospital
- Investigators
- Xianbao Zhan, Dr., Study director, Chanhai hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468244
- Sponsor's protocol ID
- CHO-01002
- Status last verified
- Feb 2019
- First submitted
- 8 Mar 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39267685
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03468244
- Acronym / sponsor ID
- CHO-01002
- Conditions
- Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Colorectal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Stemirna Therapeutics
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized mRNA Tumor Vaccine | Experimental | Biological: Personalized mRNA Tumor VaccinePersonalized mRNA Tumor Vaccine Encoding Neoantigen in Patients with Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized mRNA Tumor Vaccinesubcutaneous injection with personalized mRNA tumor vaccine at least four times | Biological | Personalized mRNA Tumor Vaccine |
Primary outcome
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
4 secondary outcomes
Disease Control Rate of Personalized mRNA Tumor Vaccine
Time frame: 1.5 years
Progression-free Survival of Personalized mRNA Tumor Vaccine
Time frame: 2 years
Time to Tumor Progression of Personalized mRNA Tumor Vaccine
Time frame: 2 years
Overall Survival of Personalized mRNA Tumor Vaccine
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Derived from this study: PubMed 39267685Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianbao Zhan, Dr. study director
Chanhai hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized mRNA Tumor Vaccine in people with Advanced Esophageal Squamous Carcinoma and Gastric Adenocarcinoma, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Wang, Dr. (+86 02131161448, qcwangb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.