Gastric Cancer Stage IIIPhase 2NCT07050524
Omega-3 Supplementation and Immunotherapy in Gastric Cancer: A Phase II Trial
A Phase 2 study testing Omega-3 Supplementation and Neoadjuvant Immunotherapy in people with Gastric Cancer Stage III, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Omega-3 fatty acids supplementation can enhance the efficacy of neoadjuvant immunotherapy in patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer Stage III
- What is being tested?
- Omega-3 Supplementation and Neoadjuvant Immunotherapy
- Type of treatment
- Pill or oral medicine, 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 Sep 2025to 30 Sep 2027
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Participants must be aged 18 years or older.
- Diagnosis: Confirmed diagnosis of locally advanced gastric or gastroesophageal junction adenocarcinoma, classified as clinical stage II or III according to the American Joint Committee on Cancer (AJCC) staging system.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicating that patients are fully active or restricted in physically strenuous activity but are capable of self-care.
- Histological Verification: Tissue confirmation of diagnosis must be obtained via biopsy, with adequate archival tumor tissue available for biomarker analysis if required.
- Organ Function: Adequate organ function as evidenced by laboratory tests:
- Absolute neutrophil count (ANC) ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) Total bilirubin ≤ 1.5 times the ULN (unless due to Gilbert's syndrome) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the ULN (≤ 5 times the ULN if liver metastases are present)
- Informed Consent: Ability and willingness to provide written informed consent prior to any study-related procedures.
Who cannot join
- Previous Therapy: Prior treatment with chemotherapy, radiation therapy, or immunotherapy for the current cancer diagnosis.
- Concurrent Malignancies: Presence of another active malignancy within the past 5 years (except for non-melanoma skin cancer or cervical carcinoma in situ).
- Active Infection: Presence of any uncontrolled infection requiring systemic therapy or serious co-morbid conditions that would compromise program compliance or interfere with study results.
- Allergies: Known hypersensitivity or contraindications to Omega-3 fatty acid supplementation or components of the immunotherapy regimen.
- Pregnancy/Breastfeeding: Women who are pregnant or breastfeeding; fertile men and women not employing effective contraception during the study period.
- Psychiatric Condition: Any psychiatric condition or substance abuse that would interfere with compliance or affect the participant's safety.
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
First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Hao Xu, 86-02568306505, zhangyg0021@163.com
About this study
Official title: Evaluating the Effect of Omega-3 Fatty Acids Supplementation on the Efficacy of Neoadjuvant Immunotherapy in Patients With Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: A Multicenter, Randomized, Controlled Phase II Clinical Trial
The goal of this clinical trial is to learn if Omega-3 fatty acids supplementation can enhance the efficacy of neoadjuvant immunotherapy in patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: does Omega-3 supplementation improve the pathologic complete response (pCR) rate compared to standard neoadjuvant immunotherapy alone, and is there an increase in the major pathological response (MPR) rate with Omega-3 supplementation? Researchers will compare the group receiving Omega-3 supplementation with the control group receiving standard neoadjuvant immunotherapy to see if Omega-3 supplementation leads to better treatment outcomes. Participants will receive Omega-3 fatty acids supplements in conjunction with their prescribed neoadjuvant immunotherapy, undergo regular assessments of their pathologic response to treatment, and provide information on their nutritional status and quality of life throughout the study.
- Conditions
- Gastric Cancer Stage III
- Being tested
- Omega-3 Supplementation, Neoadjuvant Immunotherapy
- Keywords
- omega-3, Neoadjuvant Immunotherapy, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 SupplementationDietary supplement
Participants assigned to the experimental group will receive Omega-3 fatty acids supplementation as part of their treatment regimen. The Omega-3 supplementation will consist of high-quality fish oil capsules, providing a daily dose of [specific dosage, e.g., 2000 mg of EPA and DHA combined], taken orally. This supplementation will commence concurrently with the initiation of neoadjuvant immunotherapy and will continue throughout the treatment period.
Neoadjuvant ImmunotherapyDrug
Participants in both the experimental and control groups will receive neoadjuvant immunotherapy designed to stimulate the body's immune response against locally advanced gastric and gastroesophageal junction adenocarcinomas. The specific regimen will involve administration of [specific immunotherapeutic agents, e.g., pembrolizumab, nivolumab, etc.] in accordance with established clinical protocols.
The neoadjuvant immunotherapy will be administered through intravenous infusion, typically starting [specify timeline, e.g., 4-6 weeks] prior to surgical resection of the tumor. Treatment cycles will be scheduled every [specify interval, e.g., 2 or 3 weeks], depending on the specific agent used and participant response.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Receiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy Receives: Dietary Supplement: Omega-3 Supplementation; Drug: Neoadjuvant Immunotherapy |
| control group | Active comparator | Receiving only the standard immunotherapy Receives: Drug: Neoadjuvant Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
Measured: 8 to 12 weeks
Secondary outcomes (1)
Major Pathological Response (MPR)
Measured: 8 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This interventional study employs a randomized, controlled design to evaluate the effects of Omega-3 fatty acids supplementation on the efficacy of neoadjuvant immunotherapy in patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. Participants will be randomly assigned to one of two groups: the experimental group receiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy, and the control group receiving only the standard immunotherapy. The primary endpoints include pathologic complete response (pCR) rates and major pathological response (MPR) rates. The study will also assess secondary outcomes such as nutritional status, immune function, inflammatory responses, adverse events, and quality of life metrics. By utilizing a controlled framework, this study aims to provide robust evidence regarding the potential benefits of Omega-3 supplementation in enhancing immunotherapy outcomes for gastrointestinal cancers.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Suzhou Medical College, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Jiangning Hospital of Nanjing Medical University
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050524
- Sponsor's protocol ID
- OSIRIS
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Omega-3 Fatty Acids Supplementation on the Efficacy of Neoadjuvant Immunotherapy in Patients With Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: A Multicenter, Randomized, Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07050524
- Acronym / sponsor ID
- OSIRIS
- Conditions
- Gastric Cancer Stage III
- Keywords
- omega-3, Neoadjuvant Immunotherapy, Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Suzhou Medical College, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Jiangning Hospital of Nanjing Medical University
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Jul 2025 (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 goal of this clinical trial is to learn if Omega-3 fatty acids supplementation can enhance the efficacy of neoadjuvant immunotherapy in patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: does Omega-3 supplementation improve the pathologic complete response (pCR) rate compared to standard neoadjuvant immunotherapy alone, and is there an increase in the major pathological response (MPR) rate with Omega-3 supplementation? Researchers will compare the group receiving Omega-3 supplementation with the control group receiving standard neoadjuvant immunotherapy to see if Omega-3 supplementation leads to better treatment outcomes. Participants will receive Omega-3 fatty acids supplements in conjunction with their prescribed neoadjuvant immunotherapy, undergo regular assessments of their pathologic response to treatment, and provide information on their nutritional status and quality of life throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This interventional study employs a randomized, controlled design to evaluate the effects of Omega-3 fatty acids supplementation on the efficacy of neoadjuvant immunotherapy in patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. Participants will be randomly assigned to one of two groups: the experimental group receiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy, and the control group receiving only the standard immunotherapy. The primary endpoints include pathologic complete response (pCR) rates and major pathological response (MPR) rates. The study will also assess secondary outcomes such as nutritional status, immune function, inflammatory responses, adverse events, and quality of life metrics. By utilizing a controlled framework, this study aims to provide robust evidence regarding the potential benefits of Omega-3 supplementation in enhancing immunotherapy outcomes for gastrointestinal cancers.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: Omega-3 Supplementation, Drug: Neoadjuvant ImmunotherapyReceiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy |
| control group | Active comparator | Drug: Neoadjuvant ImmunotherapyReceiving only the standard immunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: Participants must be aged 18 years or older.
- Diagnosis: Confirmed diagnosis of locally advanced gastric or gastroesophageal junction adenocarcinoma, classified as clinical stage II or III according to the American Joint Committee on Cancer (AJCC) staging system.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicating that patients are fully active or restricted in physically strenuous activity but are capable of self-care.
- Histological Verification: Tissue confirmation of diagnosis must be obtained via biopsy, with adequate archival tumor tissue available for biomarker analysis if required.
- Organ Function: Adequate organ function as evidenced by laboratory tests:
Key exclusion criteria (6 listed)
- Previous Therapy: Prior treatment with chemotherapy, radiation therapy, or immunotherapy for the current cancer diagnosis.
- Concurrent Malignancies: Presence of another active malignancy within the past 5 years (except for non-melanoma skin cancer or cervical carcinoma in situ).
- Active Infection: Presence of any uncontrolled infection requiring systemic therapy or serious co-morbid conditions that would compromise program compliance or interfere with study results.
- Allergies: Known hypersensitivity or contraindications to Omega-3 fatty acid supplementation or components of the immunotherapy regimen.
- Pregnancy/Breastfeeding: Women who are pregnant or breastfeeding; fertile men and women not employing effective contraception during the study period.
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 |
|---|---|---|
| Omega-3 SupplementationParticipants assigned to the experimental group will receive Omega-3 fatty acids supplementation as part of their treatment regimen. The Omega-3 supplementation will consist of high-quality fish oil capsules, providing a daily dose of [specific dosage, e.g., 2000 mg of EPA and DHA combined], taken orally. This supplementation will commence concurrently with the initiation of neoadjuvant immunotherapy and will continue throughout the treatment period. | Dietary supplement | experimental group |
| Neoadjuvant ImmunotherapyParticipants in both the experimental and control groups will receive neoadjuvant immunotherapy designed to stimulate the body's immune response against locally advanced gastric and gastroesophageal junction adenocarcinomas. The specific regimen will involve administration of [specific immunotherapeutic agents, e.g., pembrolizumab, nivolumab, etc.] in accordance with established clinical protocols. The neoadjuvant immunotherapy will be administered through intravenous infusion, typically starting [specify timeline, e.g., 4-6 weeks] prior to surgical resection of the tumor. Treatment cycles will be scheduled every [specify interval, e.g., 2 or 3 weeks], depending on the specific agent used and participant response. | Drug | control group, experimental group |
Primary outcome
Pathologic Complete Response (pCR)
Time frame: 8 to 12 weeks
1 secondary outcome
Major Pathological Response (MPR)
Time frame: 8 to 12 weeks
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 3 Jul 2025.
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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 2 study testing Omega-3 Supplementation and Neoadjuvant Immunotherapy in people with Gastric Cancer Stage III, run by The First Affiliated Hospital with Nanjing Medical 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 7 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: opening soon, as of the sponsor's last update on 3 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hao Xu (86-02568306505, zhangyg0021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) (time frame: 8 to 12 weeks). 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 3 Jul 2025.