Gastric CancePhase 2NCT07033143
Evaluation of the Efficacy and Safety of Adebrelimab Combined With SOX as Adjuvant Therapy for IIIB and IIIC Gastric Cancer
A Phase 2 study testing Adebrelimab+SOX in people with Gastric Cance, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
Although the immunotherapy combination regimen has shown good data and safety during the perioperative period of gastric cancer, more clinical studies are still needed to explore the treatment regimens, the number of treatment cycles, the screening of beneficiary populations, and the safety assessment of different… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cance
- What is being tested?
- Adebrelimab+SOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old, gender not limited
- Surgical pathology confirmed as stage IIIB or IIIC gastric cancer or adenocarcinoma of the gastroesophageal junction (AJCC 8th)
- The patient underwent R0 surgical resection
- Have an ECOG performance status score of 0 or 1
- There are available tumor tissues for PD-L1 expression analysis
- PD-L1 CPS ≥5
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- No liver, peritoneal or distant metastasis, and peritoneal cytology is negative
- No previous anti-tumor treatments other than surgery, including but not limited to chemotherapy, targeted therapy, and immunotherapy, have been received
- The patient's physical condition and visceral functions allow for subsequent adjuvant treatments, including chemotherapy, chemoradiotherapy, and PD-L1 inhibitor therapy.
- The patient's blood routine and biochemical indicators should meet the following standards: Hb≥90g/L, ANC≥1.5*10^9/L, PLT≥100*10^9/L, ALT and AST≤2.5 U/L, TB≤1.5 UNL, and serum creatinine <1 UNL
- Patients who were willing to follow the treatment plan during the study period
- Written informed consent must be obtained before enrollment. Patients have the right to withdraw, and subsequent treatment will not be affected.
Who cannot join
- Patients with obvious liver metastasis, peritoneal metastasis or distant metastasis;
- HER2 positive (++/+++);
- Pregnant or lactating patients;
- Received previous anti-tumor treatments, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.
- Have suffered from other malignant tumors in the past 5 years (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer);
- Uncontrollable pleural effusion, pericardial effusion or ascites;
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- Clinically determined as inoperable or with distant metastasis;
- Have suffered from severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, grade ≥II congestive heart failure, uncontrolled arrhythmia, and myocardial infarction;
- Concurrent upper gastrointestinal obstruction/bleeding or digestive dysfunction or malabsorption syndrome;
- There was a history of gastrointestinal perforation 6 months before enrollment.
- Concurrent severe and uncontrolled concurrent infections or other severe and uncontrolled concomitant diseases, moderate or severe renal injury;
- There are poorly controlled clinical symptoms or diseases of the heart, such as :(1) Grade II or above cardiac insufficiency or echocardiography examination according to the New York Heart Association (NYHA) standards (see Annex 5) :LVEF(left ventricular ejection fraction)<50%; (2) Unstable angina pectoris (3) Myocardial infarction occurred within one year before the start of the study treatment; (4) Supraventricular or ventricular arrhythmias of clinical significance require treatment or intervention; (5)QTc>450ms(male); QTc>470ms(for females)(The QTc interval is calculated using the Fridericia formula; If the QTc is abnormal, three consecutive tests can be conducted at intervals of 2 minutes, and the average value can be taken.
- Allergic reactions to the drugs used in this study;
- Immunosuppressive drugs have been used within 4 weeks before the first dose of the study treatment, excluding topical glucocorticoids through nasal spray, inhalation or other routes, or systemic glucocorticoids at physiological doses (i.e., no more than 10mg/ day prednisone or equivalent doses of other glucocorticoids), or hormones used for the prevention of contrast agent allergy;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Those currently accompanied by interstitial pneumonia or interstitial lung disease, or those with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis and organized pneumonia that may interfere with the judgment and management of immune-related pulmonary toxicity (for example, Subjects with oblusive bronchiolitis, pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia, or those with evidence of active pneumonia or severely impaired lung function shown on chest computed tomography (CT) images during the screening period are allowed to have radiation pneumonia and active tuberculosis in the radiation field.
- There is an active autoimmune disease or a history of autoimmune diseases that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitinitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled only through hormone replacement therapy can be included]); Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes treated with insulin, or asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included. Asthma patients who require medical intervention with bronchodilators cannot be included.
- Use immunosuppressants or systemic hormone therapy within 14 days before the initiation of the study treatment to achieve the purpose of immunosuppression (dose >10mg/ day prednisone or other therapeutic hormones);
- There was a severe infection within 4 weeks before the initiation of the study treatment, including but not limited to hospitalization due to infection, bacteremia or complications of severe pneumonia; Therapeutic antibiotics were administered orally or intravenously within 2 weeks before the initiation of the study treatment (patients receiving preventive antibiotics (for example, those who are eligible to participate in the study to prevent urinary tract infections or exacerbation of chronic obstructive pulmonary disease);
- Patients with congenital or acquired immune deficiency (such as HIV-infected individuals);
- Immunosuppressive drugs have been used within 4 weeks before the first administration;
- The attenuated live vaccine has been administered within 4 weeks before the first administration or is planned to be administered during the study period;
- Has received other anti-PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1 in the past;
- Received treatment with other investigational drugs within 28 days before the initiation of the study treatment;
- Unresolved postoperative complications;
- According to the researcher's judgment, the patient has other factors that may affect the research results or lead to the forced termination of this study halfway, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors, etc., which will affect the patient's safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Although the immunotherapy combination regimen has shown good data and safety during the perioperative period of gastric cancer, more clinical studies are still needed to explore the treatment regimens, the number of treatment cycles, the screening of beneficiary populations, and the safety assessment of different drug combinations of immunotherapy combination therapy as adjuvant treatment after gastric cancer surgery.
Read the detailed description
Although the immunotherapy combination regimen has shown good data and safety during the perioperative period of gastric cancer, more clinical studies are still needed to explore the treatment regimens, the number of treatment cycles, the screening of beneficiary populations, and the safety assessment of different drug combinations of immunotherapy combination therapy as adjuvant treatment after gastric cancer surgery.
- Conditions
- Gastric Cance
- Being tested
- Adebrelimab+SOX
- Keywords
- Adjuvant therapy for gastric cancer, Combined immunotherapy, PD-L1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab+SOXDrug
Adebrelimab: 1200mg, intravenous drip, day 1, 21 days as one cycle, treatment duration is 1 year.
SOX: Eight cycles after the operation, intravenous infusion of oxaliplatin at 130 mg/m2. On the first day, oral administration of S-1 at 40-60 mg twice a day. From the first to the 14th day, 21 days constitute one cycle.
Enhanced CT examinations of the chest, abdomen and pelvis were conducted every 9-12 weeks in the first year of treatment. Then have a check-up every 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Adebrelimab combined with SOX treatment for 8 cycles, and Adebrelimab maintenance treatment until 1 year Receives: Drug: Adebrelimab+SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year-DFS rate
3-year disease-free survival rate
Measured: up to 3 year
Secondary outcomes (2)
OS
overall survival
Measured: up to 5 year
AE
The incidence rate and grade (including serious adverse events and immune-related adverse events) were determined according to the NCI-CTCAE5.0 criteria
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CanceStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033143
- Sponsor's protocol ID
- GC-Adjuvant-001
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Adebrelimab Combined With SOX as Adjuvant Therapy for IIIB and IIIC Gastric Cancer
- ClinicalTrials.gov ID
- NCT07033143
- Acronym / sponsor ID
- GC-Adjuvant-001
- Conditions
- Gastric Cance
- Keywords
- Adjuvant therapy for gastric cancer, Combined immunotherapy, PD-L1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 24 Jun 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.
Although the immunotherapy combination regimen has shown good data and safety during the perioperative period of gastric cancer, more clinical studies are still needed to explore the treatment regimens, the number of treatment cycles, the screening of beneficiary populations, and the safety assessment of different drug combinations of immunotherapy combination therapy as adjuvant treatment after gastric cancer surgery.
Detailed description
Although the immunotherapy combination regimen has shown good data and safety during the perioperative period of gastric cancer, more clinical studies are still needed to explore the treatment regimens, the number of treatment cycles, the screening of beneficiary populations, and the safety assessment of different drug combinations of immunotherapy combination therapy as adjuvant treatment after gastric cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Adebrelimab+SOXAdebrelimab combined with SOX treatment for 8 cycles, and Adebrelimab maintenance treatment until 1 year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 75 years old, gender not limited
- Surgical pathology confirmed as stage IIIB or IIIC gastric cancer or adenocarcinoma of the gastroesophageal junction (AJCC 8th)
- The patient underwent R0 surgical resection
- Have an ECOG performance status score of 0 or 1
- There are available tumor tissues for PD-L1 expression analysis
Key exclusion criteria (26 listed)
- Patients with obvious liver metastasis, peritoneal metastasis or distant metastasis;
- HER2 positive (++/+++);
- Pregnant or lactating patients;
- Received previous anti-tumor treatments, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.
- Have suffered from other malignant tumors in the past 5 years (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer);
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 |
|---|---|---|
| Adebrelimab+SOXAdebrelimab: 1200mg, intravenous drip, day 1, 21 days as one cycle, treatment duration is 1 year. SOX: Eight cycles after the operation, intravenous infusion of oxaliplatin at 130 mg/m2. On the first day, oral administration of S-1 at 40-60 mg twice a day. From the first to the 14th day, 21 days constitute one cycle. Enhanced CT examinations of the chest, abdomen and pelvis were conducted every 9-12 weeks in the first year of treatment. Then have a check-up every 24 weeks. | Drug | Arm 1 |
Primary outcome
3-year-DFS rate
Time frame: up to 3 year
3-year disease-free survival rate
2 secondary outcomes
OS
Time frame: up to 5 year
AE
Time frame: up to 5 year
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 24 Jun 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab+SOX in people with Gastric Cance, run by Tianjin Medical University Cancer Institute and Hospital.
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 12 inclusion and 26 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hongjie Zhan Tianjin Cancer Hospital Airport Hospital, Director (18622228706, 83951546@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year-DFS rate (time frame: up to 3 year). 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 24 Jun 2025.