Actively Recruiting
Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Led by Shandong Provincial Hospital · Updated on 2026-04-29
32
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and provide informed consent with good compliance and follow-up
- Confirmed adenocarcinoma of the gastric or gastroesophageal junction by endoscopic pathology
- Clinical stage cT4N+M0 according to AJCC stage 8 combined with imaging findings
- Age between 18 and 75 years, male or female
- ECOG performance status score of 0 or 1
- Presence of measurable or unmeasurable lesions per RECIST 1.1 criteria
- No prior systemic antitumor therapy such as chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Adequate vital organ function with specified blood counts and liver, kidney function within set limits
- Fertile female subjects must have a negative pregnancy test within 72 hours before first drug administration and agree to use effective contraception during and for 5 months after treatment; males with partners of reproductive age must also use effective contraception during and for 7 months after treatment
You will not qualify if you...
- History of surgery for gastric or gastroesophageal junction tumors
- Previous fistula caused by primary tumor invasion
- High risk of gastrointestinal bleeding or perforation
- Poor nutritional status with BMI under 18.5 or PG-SGA score of 9 or higher
- Major surgery or severe trauma within 4 weeks before first study drug use
- Uncontrolled pleural, pericardial effusion or ascites needing repeated drainage
- History of or current treatment with anti-PD-1/PD-L1 therapy, chemotherapy, radiotherapy, or targeted therapy
- Use of investigational drugs within 4 weeks before first study drug use
- Need for systemic corticosteroids above 10 mg prednisone daily or immunosuppressants within 2 weeks before treatment, except for certain local steroid uses
- Recent use of antitumor or live vaccines within 4 weeks before first drug administration
- Active or history of autoimmune diseases except certain controlled conditions
- History of immunodeficiency or organ/bone marrow transplantation
- Uncontrolled cardiac conditions or significant heart disease
- Recent severe infections or lung inflammation requiring treatment
- History or active pulmonary tuberculosis within 1 year or untreated past infection
- Active hepatitis B or hepatitis C infections
- Electrolyte abnormalities uncorrected within 2 weeks before enrollment
- Allergies to study drug components or related agents
- Prior diagnosis of other malignancies except low-risk treated cancers
- Pregnant or breastfeeding women, or unwillingness/inability to use contraception
- Other serious diseases or conditions that may interfere with study participation or safety as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Actively Recruiting
Research Team
L
Liang Shang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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