Locally Advanced Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2STAR-02NCT06766578
Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Neoadjuvant Therapy(5×3Gy radiotherapy), Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1) and Surgical treatment in people with Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
To evaluate the initial efficacy and safety of neoadjuvant low-dose interval radiotherapy combined with tirelizumab and SOX chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Neoadjuvant Therapy(5×3Gy radiotherapy), Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1) and Surgical treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participated in the study and signed informed consent with good compliance and follow-up;
- Adenocarcinoma of the gastric/gastroesophageal junction confirmed by endoscopic pathology (tumor located in the lesser bend of the stomach other than pylorus or the gastroesophageal junction) (Note: Pathology in other hospitals must be consulted by our hospital);
- Patients with cT4N+M0 AJCC stage 8 combined with endoscopic, CT, MRI, or PETCT findings;
- Age ≥18 years, ≤75 years, male and female;
- ECOG PS score 0-1;
- Presence of measurable and/or unmeasurable lesions as defined by the efficacy evaluation criteria for solid tumors (Recist 1.1);
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- Has not received any prior systemic antitumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biotherapy, topical therapy, or other investigational therapeutic drugs;
- The functions of vital organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before screening) : Neutrophil absolute count (ANC) ≥ 1.5×10 9/L; Platelets ≥100×10 9/L; Hemoglobin ≥9g/dL; Serum albumin ≥2.8g/dL; Total bilirubin ≤ 1.5 ×ULN, ALT, AST and/or AKP≤2.5 ×ULN; serum creatinine ≤1.5 ×ULN or creatinine clearance ≥60mL/min (calculated according to the Cockcroft-Gault formula); International standardized ratio (INR) and activated partial thrombin time (APTT) ≤1.5×ULN (INR can be screened in the expected treatment range of anticoagulants for stable doses of anticoagulants such as low molecular weight heparin or warfarin);
- Fertile female subjects shall perform a urine or serum pregnancy test within 72 hours prior to receiving the first study drug, prove negative, and be willing to use an effective method of contraception during the trial period up to 5 months after the last drug administration.Male subjects whose partner is a woman of reproductive age should use an effective method of contraception during the trial period and for 7 months after the last dose.
Who cannot join
- a history of surgery for gastric/esophagogastric junction tumors;
- Previous history of fistula caused by primary tumor invasion;
- Higher risk of gastrointestinal bleeding and perforation;
- Poor nutritional status, BMI less than 18.5kg/m2, or PG-SGA score ≥9;
- Major surgery or severe trauma within 4 weeks prior to first use of the study drug;
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
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- has received or is currently receiving any of the following previous treatments: anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy;
- Received any investigational drug within 4 weeks prior to first use of the investigational drug;
- subjects requiring systemic treatment with corticosteroids (> 10mg prednisone equivalent daily dose) or other immunosuppressants within 2 weeks prior to initial use of the study drug, except for corticosteroids for esophageal/gastric local inflammation and for the prevention of allergy and nausea and vomiting.Other special circumstances, need to communicate with the bid. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at doses > 10mg/ d of prednisone efficacy are permitted;
- those who have received antitumor vaccine or have received live vaccine within 4 weeks prior to the first administration of the study drug;
- have any active autoimmune disease or a history of autoimmune disease (such as interstitial pulmonary inflammation, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except patients with vitiligo or recovered asthma/allergy of the same age without any intervention as adults;Patients with autoimmune mediated hypothyroidism treated with stable doses of thyroid hormone replacement and type 1 diabetes treated with stable doses of insulin could be included;
- have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;
- any condition requiring systemic treatment with corticosteroids (more than 10 mg/ day of prednisone or its equivalent) or other immunosuppressant treatment within 14 days prior to treatment (except local, ocular, intraarticular, intranasal and inhaled corticosteroids with minimal systemic uptake); Prophylactic short-term (≤7 days) use of corticosteroids (e.g., to prevent contrast allergy) or for the treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to allergen exposure);
- subjects with uncontrolled cardiac clinical symptoms or disease, such as (1) NYHA II or above heart failure (2) unstable angina pecina (3) myocardial infarction within 1 year (4) clinically significant ventricular arrhythmias or ventricular arrhythmias requiring clinical intervention;
- Severe infection (CTCAE > level 2), such as severe pneumonia, bacteremia, and infectious complications requiring hospitalization, occurred within 4 weeks prior to initial use of the study drug; Chest imaging at baseline suggested active lung inflammation and signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, except for prophylactic antibiotic use;
- a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis or other uncontrolled acute lung disease;
- Patients with active pulmonary tuberculosis infection found by history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis infection history more than 1 year ago but without formal treatment;
- Subjects with active hepatitis B (HBV DNA≥2000 IU/mL or 10 4 Copies /mL), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of detection method);
- Abnormal values of sodium, potassium and calcium greater than grade 1 in laboratory tests within 2 weeks before enrollment, which could not be improved after treatment;
- known allergy to macromolecular protein preparations, or to any COMPONENT of PD-1, or allergy, hypersensitivity or contraindication to oxaliplatin or capecitabine or any component used in their preparations;
- A prior diagnosis of any other malignancy, other than malignancies with a low risk of metastasis and death (5-year survival > 90%), such as adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix;
- pregnant or lactating women; Fertile subjects unwilling or unable to use effective contraception;
- According to the investigator's judgment, subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental diseases) requiring combined treatment, other recent serious diseases (such as myocardial infarction and cerebrovascular accident) with high risk of recurrence, seriously abnormal laboratory test values, family or social factors, which may affect subjects' safety or the collection of test data.
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
Shandong Provincial Hospital
Jinan, Shandong, 250021
Liang Shang, doctor, 15866602157, shangliang@sdfmu.edu.cn
About this study
Official title: Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma(STAR-02)
To evaluate the initial efficacy and safety of neoadjuvant low-dose interval radiotherapy combined with tirelizumab and SOX chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma.
- Being tested
- Neoadjuvant Therapy(5×3Gy radiotherapy), Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1), Surgical treatment, Adjuvant therapy(SOX chemotherapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Therapy(5×3Gy radiotherapy)Radiation
Radiotherapy: 5×3Gy. The preoperative radiotherapy target was outlined by radiotherapy physicians according to the NCCN Guidelines for Gastric/esophagogastric Junction Tumor 2024 edition and the surgeon's opinions. The first and third cycles were 5×3Gy.
Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1)Drug
The first and third cycles are 5×3Gy radiotherapy D1 to 5, intravenous administration for tirelizumab 200 mg D6, intravenous administration for oxaliplatin 130 mg/m2 D6, and oral administration twice a day for S-1 40 mg/m2 D6 to 19. The second and fourth cycles are intravenous administration for tirelizumab 200 mg D1, intravenous administration for oxaliplatin 130 mg/m2 D1, and oral administration twice a day for S-1 40 mg/m2 D1 to 14. Every treatment cycle is spaced 1 week apart.
Surgical treatmentProcedure or surgery
Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy.
Adjuvant therapy(SOX chemotherapy)Drug
Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1) | Experimental | Not described Receives: Radiation: Neoadjuvant Therapy(5×3Gy radiotherapy); Drug: Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1); Procedure: Surgical treatment; Drug: Adjuvant therapy(SOX chemotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Pathological complete response was defined as pT0N0M0
Measured: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.
Secondary outcomes (8)
Major pathological response rate (MPR)
The percentage of surviving tumor cells in the tumor bed after neoadjuvant therapy was ≤10%.
Measured: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.
Objective response rate (ORR)
Proportion of patients who achieved a complete response (CR) or a partial response (PR) as assessed by RECIST 1.1.
Measured: From date of neoadjuvant therapy until the date of surgery, assessed up to 15-17 weeks.
R0 resection rate
The proportion of patients who completed R0 resection in the total enrolled patients.
Measured: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.
Treatment safety
CTCAE 5.0 was used to record grade 3 and above treatment-related adverse reactions from the beginning of neoadjuvant therapy to 30 days after the end of surgery.
Measured: From date of neoadjuvant therapy until the date of 30 days post-surgery, assessed up to 19-21 weeks.
Postoperative complications
Clavien-Dindo criteria were used to evaluate.
Measured: The first 30 days following surgery.
Event-free survival (EFS)
From the beginning of the study to the time of the first occurrence of any of the following events, disease progression beyond surgical treatment, local or distant recurrence, death from any cause, etc.
Measured: From date of neoadjuvant therapy until the date of the first occurrence of the above events, assessed up to 60 months.
Overall survival (OS)
From study inception to patient death from any cause.
Measured: From the date of diagnosis to the date of death, assessed up to 60 months.
Biomarkers
By collecting tumor tissue and hematology samples before and after neoadjuvant therapy, scRNA-seq, WES, MRD and other techniques were used to explore biomarkers related to the efficacy of immunotherapy combined with radiotherapy and chemotherapy.
Measured: From the date of neoadjuvant therapy until the end of postoperative follow-up, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start30 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric/Gastroesophageal Junction AdenocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Leping, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766578
- Sponsor's protocol ID
- NO.2024-1047
- Acronym
- STAR-02
- Status last verified
- Apr 2026
- First submitted
- 29 Dec 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma(STAR-02)
- ClinicalTrials.gov ID
- NCT06766578
- Acronym / sponsor ID
- STAR-02 / NO.2024-1047
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jan 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.
To evaluate the initial efficacy and safety of neoadjuvant low-dose interval radiotherapy combined with tirelizumab and SOX chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1) | Experimental | Radiation: Neoadjuvant Therapy(5×3Gy radiotherapy), Drug: Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1), Procedure: Surgical treatment, Drug: Adjuvant therapy(SOX chemotherapy) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients voluntarily participated in the study and signed informed consent with good compliance and follow-up;
- Adenocarcinoma of the gastric/gastroesophageal junction confirmed by endoscopic pathology (tumor located in the lesser bend of the stomach other than pylorus or the gastroesophageal junction) (Note: Pathology in other hospitals must be consulted by our hospital);
- Patients with cT4N+M0 AJCC stage 8 combined with endoscopic, CT, MRI, or PETCT findings;
- Age ≥18 years, ≤75 years, male and female;
- ECOG PS score 0-1;
Key exclusion criteria (23 listed)
- a history of surgery for gastric/esophagogastric junction tumors;
- Previous history of fistula caused by primary tumor invasion;
- Higher risk of gastrointestinal bleeding and perforation;
- Poor nutritional status, BMI less than 18.5kg/m2, or PG-SGA score ≥9;
- Major surgery or severe trauma within 4 weeks prior to first use of the study drug;
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 |
|---|---|---|
| Neoadjuvant Therapy(5×3Gy radiotherapy)Radiotherapy: 5×3Gy. The preoperative radiotherapy target was outlined by radiotherapy physicians according to the NCCN Guidelines for Gastric/esophagogastric Junction Tumor 2024 edition and the surgeon's opinions. The first and third cycles were 5×3Gy. | Radiation | treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1) |
| Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1)The first and third cycles are 5×3Gy radiotherapy D1 to 5, intravenous administration for tirelizumab 200 mg D6, intravenous administration for oxaliplatin 130 mg/m2 D6, and oral administration twice a day for S-1 40 mg/m2 D6 to 19. The second and fourth cycles are intravenous administration for tirelizumab 200 mg D1, intravenous administration for oxaliplatin 130 mg/m2 D1, and oral administration twice a day for S-1 40 mg/m2 D1 to 14. Every treatment cycle is spaced 1 week apart. | Drug | treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1) |
| Surgical treatmentSurgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy. | Procedure or surgery | treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1) |
| Adjuvant therapy(SOX chemotherapy)Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy. | Drug | treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1) |
Primary outcome
Pathological complete response rate (pCR)
Time frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.
Pathological complete response was defined as pT0N0M0
8 secondary outcomes
Major pathological response rate (MPR)
Time frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.
Objective response rate (ORR)
Time frame: From date of neoadjuvant therapy until the date of surgery, assessed up to 15-17 weeks.
R0 resection rate
Time frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.
Treatment safety
Time frame: From date of neoadjuvant therapy until the date of 30 days post-surgery, assessed up to 19-21 weeks.
Postoperative complications
Time frame: The first 30 days following surgery.
Event-free survival (EFS)
Time frame: From date of neoadjuvant therapy until the date of the first occurrence of the above events, assessed up to 60 months.
Overall survival (OS)
Time frame: From the date of diagnosis to the date of death, assessed up to 60 months.
Biomarkers
Time frame: From the date of neoadjuvant therapy until the end of postoperative follow-up, assessed up to 60 months.
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 29 Apr 2026.
- 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.
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 Neoadjuvant Therapy(5×3Gy radiotherapy), Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1) and Surgical treatment in people with Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, run by Shandong Provincial 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 9 inclusion and 23 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 29 Apr 2026. 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 Liang Shang (+8615866602157, docshang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 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 29 Apr 2026.