Gastric CancerPhase 1NCT04147078
Personalized DC Vaccine for Postoperative Cancer
A Phase 1 study testing DC vaccine subcutaneous administration in people with Gastric Cancer and Hepatocellular Carcinoma, run by Sichuan University at 1 site in China.
Trial summary
The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastric Cancer, Hepatocellular Carcinoma, Non-Small-Cell Lung Cancer
- What is being tested?
- DC vaccine subcutaneous administration
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation
- Anticipated life time > 3month
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Adequate organ functions
Who cannot join
- Any evidence of tumor metastasis or co-existing malignant disease
- Tumor emergency
- Abnormal coagulation condition
- Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
- Concomitant tumors
- Immunological co-morbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qiu Li
Chengdu, Sichuan, 610041
Qiu Li, PhD, +86 028-85422589, liqiu@scu.edu.cn
Qiu Li, +86 028-85422589, liqiu@scu.edu.cn
About this study
Official title: Adjuvant Treatment in Cancer Patients with Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial
The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.
Read the detailed description
Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
- Being tested
- DC vaccine subcutaneous administration
- Keywords
- Cell therapy, safety, clinical efficacy, adjuvant treatment, locally advanced cancer
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC vaccine subcutaneous administrationBiological
subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| cell_therapy | Experimental | tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times Receives: Biological: DC vaccine subcutaneous administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first
Measured: Up to 5 years
Secondary outcomes (2)
Overall Survival (OS)
Defined by the time between the date of randomization and the date of death
Measured: Up to 10 years
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Defined by treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 months after the last administration of cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147078
- Sponsor's protocol ID
- CHANT-191
- Status last verified
- Feb 2025
- First submitted
- 24 Aug 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Treatment in Cancer Patients with Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04147078
- Acronym / sponsor ID
- CHANT-191
- Keywords
- Cell therapy, safety, clinical efficacy, adjuvant treatment, locally advanced cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 31 Oct 2019 (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.
The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.
Detailed description
Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cell_therapy | Experimental | Biological: DC vaccine subcutaneous administrationtumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation
- Anticipated life time > 3month
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Adequate organ functions
Key exclusion criteria (6 listed)
- Any evidence of tumor metastasis or co-existing malignant disease
- Tumor emergency
- Abnormal coagulation condition
- Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
- Concomitant tumors
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 |
|---|---|---|
| DC vaccine subcutaneous administrationsubcutaneous administration | Biological | cell_therapy |
Primary outcome
Disease-free Survival (DFS)
Time frame: Up to 5 years
Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to 10 years
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Time frame: 3 months after the last administration of cells
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC vaccine subcutaneous administration in people with Gastric Cancer and Hepatocellular Carcinoma, run by Sichuan University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiu Li (+86 028-85422589, liqiu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (DFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.