Gastric CancerNCT05227378
Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Gastric Cancer
A study testing neoantigen tumor vaccine with or without PD-1/L1 in people with Gastric Cancer, run by Shen Lin at 1 site in China.
Trial summary
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, including two phases: dose escalation and dose expansion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- neoantigen tumor vaccine with or without PD-1/L1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Mar 2022to Aug 2025
- 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
- Voluntarily signed and provided formal informed consent;
- Male and female patients aged 18-75 years (inclusive);
- Expected survival ≥ 3 months;
- Subject with advanced gastric cancer proved by histopathology or cytology and who have failed to respond to standard treatment;
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors RECIST v1.1 (see Appendix 4, Response Evaluation Criteria in Solid Tumors) (i.e., mass ≥ 10 mm in diameter and malignant lymph node ≥ 15 mm in short diameter on enhanced spiral CT ≤ 5 mm);
- ECOG performance status score of 0 ~ 2;
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- Treatment with other antineoplastic agents (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy) for more than 5 half-lives of this agent or more than 4 weeks from baseline (whichever is shorter) during the baseline period ;
- The organ function level must meet the following requirements (no blood transfusion or blood products, no hematopoietic stimulating factors, no albumin or blood products): absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count (PLT) ≥ 75 × 10^9/L, hemoglobin (Hb) ≥ 90 g/L; serum total bilirubin (TBIL) ≤ 1.5 ×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (if there is liver metastasis, total bilirubin ≤ 3 ×ULN, AST, ALT ≤ 5 ×ULN are allowed); Note: These laboratory tests may only be repeated once if the investigator deems it necessary (the reason for retest must be documented). If the criteria are met after retest, the laboratory parameter can be considered qualified.
- Premenopausal women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and be non-lactating; women of non-childbearing potential are not required to have a pregnancy test and contraception unless participants are 50 years of age or older, have not used hormonal therapy and have been amenorrheic for at least 12 months, or have been surgically sterilized. All subjects (male or female) should use adequate barrier contraception throughout treatment and for 3 months after the end of treatment.
Who cannot join
- Subject who need to receive systemic application of anti-allergic drugs for a long time, or have a history of life-threatening allergic reactions to any vaccine or drug;
- Symptomatic or rapidly progressive central nervous system metastases. Patients with extensive lung metastases resulting in dyspnea; patients with tumors close to or invading major blood vessels or nerves;
- New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening;
- Subject with acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, 5. New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) and other cardiovascular diseases;
- 6. Subject who have received treatment with immunomodulatory drugs 4 times before the first vaccination day (D1), including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-α (except for high-risk surgical subjects who use IFN-α as adjuvant therapy, if IFN-α treatment is stopped 4 times before this trial); 7. Subject with a history of renal insufficiency, serum creatinine level greater than 1.5 times the upper limit of normal; 8. Subject who received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) before baseline; 9. Subject with skin diseases (e.g., psoriasis) at baseline that may prevent the intradermal injection of vaccine into the target area; 10. Subject still suffer from adverse reactions (except alopecia and platinum-induced neurotoxicity ≤ grade 2) that have not been restored to CTCAE version 5.0 grade ≤ 1 after previous anti-tumor treatment during the screening period; 11. Concomitant use of steroid hormone drugs (tumor or non-tumor related diseases) is required; however, topical application (not applied to the vaccination site) or inhaled steroid drugs are required; 12. Subject has an active infection or uncontrollable infection (except for simple urinary tract infection or upper respiratory tract infection) requiring systemic treatment; subjects with positive human immunodeficiency virus antibody, hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus deoxyribonucleic acid > 103 copies/mL, hepatitis C virus antibody, Treponema pallidum-specific antibody in virological monitoring during the screening period; Hypertension poorly controlled on treatment (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg); 13. Subject with other malignant tumors within 5 years before the screening period, except for cervical carcinoma in situ, breast carcinoma in situ and cutaneous basal cell carcinoma that have received appropriate treatment and met the recovery criteria; 14. Subject with a history of autoimmune diseases [such as, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or hypothyroidism caused by chemoradiotherapy can be included), subjects with vitiligo or recovered asthma can be included without any intervention, and subjects with asthma requiring bronchodilators for medical intervention cannot be included]; 15. Subject with active ulcer or gastrointestinal bleeding during the screening period; 16. Subject who has previously received similar therapeutic tumor vaccines; 17. Subject with congenital or acquired immunodeficiency; 18. Subject still participating in other clinical trials and not enrolled at the screening period; 19. Subject has a known alcohol or drug addiction; 20. Subject who is unable or unwilling to comply with the study protocol due to potential health, mental or social conditions in the opinion of the investigator; 21. Other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of GI Oncology, Peking University Cancer Hospital,
Beijing
Jian LI, MD, 010-88196561
Lin SHEN, MD
About this study
Official title: A Singlre Arm, Open Label Study on the Safety and Efficacy of Neoantigen Tumor Vaccine in Advanced Gastric Cancer
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose.
Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12.
Read more
In the dose escalation phase, 18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (6 subjects in 100 μg, 6 subjects in 200 μg and 6 subjects in 400 μg). The low dose group was enrolled first, and the next dose group was started when the number of subjects met the requirements. If any subject withdrew early, the low dose group was given priority.
The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.
Read the detailed description
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose.
Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12.
In the dose escalation phase, 18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (6 subjects in 100 μg, 6 subjects in 200 μg and 6 subjects in 400 μg). The low dose group was enrolled first, and the next dose group was started when the number of subjects met the requirements. If any subject withdrew early, the low dose group was given priority.
The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.
- Conditions
- Gastric Cancer
- Being tested
- neoantigen tumor vaccine with or without PD-1/L1
- Keywords
- gastric cancer, neoantigen, tumor vaccine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoantigen tumor vaccine with or without PD-1/L1Biological
personalized neoantigen tumor vaccine with or without PD-1/L1
| Study group | Role | What they receive |
|---|---|---|
| neoantigen tumor vaccine | Experimental | neoantigen tumor vaccine with or without PD-1/L1 Receives: Biological: neoantigen tumor vaccine with or without PD-1/L1 |
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 v5.0
adverse events (CTCAE 5.0), laboratory tests (hematology, blood biochemistry, coagulation and urinalysis), ECG, echocardiography, vital signs and physical examination
Measured: Up to 100 weeks
Objective Response Rate (ORR)
Objective response rate (ORR): percentage of subjects who achieve complete response (CR) and partial response (PR) according to RECIST 1.1
Measured: Up to 100 weeks
Secondary outcomes (4)
Recommended dose for further development
Recommended dose for further clinical development
Measured: Up to 16 weeks
Progression Free Survival (PFS)
the time (in days) from the first dose of study treatment to the occurrence of disease progression; for subjects who die due to other causes before disease progression, the time (in days) from the date of entry into the treatment period to the date of death will be calculated, whichever occurs first. Response determination will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: Up to 100 weeks
Serum cytokine
Serum cytokine from time zero to time of last dose concentration
Measured: Up to 16 weeks
Lymphocyte
CD3+ 、CD3+∕CD4+ %、CD3+∕CD8+ %、CD4∕CD8 、CD3-∕CD19+ % from time zero to time of last dose concentration
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (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.
- 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
- Model description
- single-center, open-label, single-arm exploratory study
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Lin
- Sponsor type
- University, hospital or other
- Collaborators
- NeoCura
- Responsible party
- Sponsor-investigator, Shen Lin, Peking University
- Investigators
- LIN SHEN, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227378
- Sponsor's protocol ID
- XKY-1004
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2022
- Last updated
- 7 Feb 2022
- 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 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Singlre Arm, Open Label Study on the Safety and Efficacy of Neoantigen Tumor Vaccine in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT05227378
- Acronym / sponsor ID
- XKY-1004
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, neoantigen, tumor vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shen LinUniversity, hospital or other
- Collaborators
- NeoCura
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 Feb 2022 (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.
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose.
Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12.
In the dose escalation phase, 18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (6 subjects in 100 μg, 6 subjects in 200 μg and 6 subjects in 400 μg). The low dose group was enrolled first, and the next dose group was started when the number of subjects met the requirements. If any subject withdrew early, the low dose group was given priority.
The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.
Detailed description
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose.
Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12.
In the dose escalation phase, 18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (6 subjects in 100 μg, 6 subjects in 200 μg and 6 subjects in 400 μg). The low dose group was enrolled first, and the next dose group was started when the number of subjects met the requirements. If any subject withdrew early, the low dose group was given priority.
The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, open-label, single-arm exploratory study
| Arm | Type | Receives |
|---|---|---|
| neoantigen tumor vaccine | Experimental | Biological: neoantigen tumor vaccine with or without PD-1/L1neoantigen tumor vaccine with or without PD-1/L1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily signed and provided formal informed consent;
- Male and female patients aged 18-75 years (inclusive);
- Expected survival ≥ 3 months;
- Subject with advanced gastric cancer proved by histopathology or cytology and who have failed to respond to standard treatment;
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors RECIST v1.1 (see Appendix 4, Response Evaluation Criteria in Solid Tumors) (i.e., mass ≥ 10 mm in diameter and malignant lymph node ≥ 15 mm in short diameter on enhanced spiral CT ≤ 5 mm);
Key exclusion criteria (5 listed)
- Subject who need to receive systemic application of anti-allergic drugs for a long time, or have a history of life-threatening allergic reactions to any vaccine or drug;
- Symptomatic or rapidly progressive central nervous system metastases. Patients with extensive lung metastases resulting in dyspnea; patients with tumors close to or invading major blood vessels or nerves;
- New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening;
- Subject with acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, 5. New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) and other cardiovascular diseases;
- 6. Subject who have received treatment with immunomodulatory drugs 4 times before the first vaccination day (D1), including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-α (except for high-risk surgical subjects who use IFN-α as adjuvant therapy, if IFN-α treatment is stopped 4 times before this trial); 7. Subject with a history of renal insufficiency, serum creatinine level greater than 1.5 times the upper limit of normal; 8. Subject who received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) before baseline; 9. Subject with skin diseases (e.g., psoriasis) at baseline that may prevent the intradermal injection of vaccine into the target area; 10. Subject still suffer from adverse reactions (except alopecia and platinum-induced neurotoxicity ≤ grade 2) that have not been restored to CTCAE version 5.0 grade ≤ 1 after previous anti-tumor treatment during the screening period; 11. Concomitant use of steroid hormone drugs (tumor or non-tumor related diseases) is required; however, topical application (not applied to the vaccination site) or inhaled steroid drugs are required; 12. Subject has an active infection or uncontrollable infection (except for simple urinary tract infection or upper respiratory tract infection) requiring systemic treatment; subjects with positive human immunodeficiency virus antibody, hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus deoxyribonucleic acid > 103 copies/mL, hepatitis C virus antibody, Treponema pallidum-specific antibody in virological monitoring during the screening period; Hypertension poorly controlled on treatment (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg); 13. Subject with other malignant tumors within 5 years before the screening period, except for cervical carcinoma in situ, breast carcinoma in situ and cutaneous basal cell carcinoma that have received appropriate treatment and met the recovery criteria; 14. Subject with a history of autoimmune diseases [such as, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or hypothyroidism caused by chemoradiotherapy can be included), subjects with vitiligo or recovered asthma can be included without any intervention, and subjects with asthma requiring bronchodilators for medical intervention cannot be included]; 15. Subject with active ulcer or gastrointestinal bleeding during the screening period; 16. Subject who has previously received similar therapeutic tumor vaccines; 17. Subject with congenital or acquired immunodeficiency; 18. Subject still participating in other clinical trials and not enrolled at the screening period; 19. Subject has a known alcohol or drug addiction; 20. Subject who is unable or unwilling to comply with the study protocol due to potential health, mental or social conditions in the opinion of the investigator; 21. Other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.
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 |
|---|---|---|
| neoantigen tumor vaccine with or without PD-1/L1personalized neoantigen tumor vaccine with or without PD-1/L1 | Biological | neoantigen tumor vaccine |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 100 weeks
adverse events (CTCAE 5.0), laboratory tests (hematology, blood biochemistry, coagulation and urinalysis), ECG, echocardiography, vital signs and physical examination
Objective Response Rate (ORR)
Time frame: Up to 100 weeks
Objective response rate (ORR): percentage of subjects who achieve complete response (CR) and partial response (PR) according to RECIST 1.1
4 secondary outcomes
Recommended dose for further development
Time frame: Up to 16 weeks
Progression Free Survival (PFS)
Time frame: Up to 100 weeks
Serum cytokine
Time frame: Up to 16 weeks
Lymphocyte
Time frame: Up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- 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. This study is not recruiting at the moment.
LIN SHEN, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neoantigen tumor vaccine with or without PD-1/L1 in people with Gastric Cancer, run by Shen Lin 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 9 inclusion and 5 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 7 Feb 2022. 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 Lin SHEN, MD (010-88196561, linshenpku@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 v5.0 (time frame: Up to 100 weeks). The study lists 2 primary outcomes in all. 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 7 Feb 2022.