Actively Recruiting
A Prospective Cohort Study on Treatment of Locally Advanced Gastric Cancer Using SOX Chemotherapy, Tislelizumab, and HIPEC
Led by Southwest Hospital, China · Updated on 2025-01-07
122
Participants Needed
2
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of combining Tislelizumab with the SOX chemotherapy regimen and hyperthermic intraperitoneal chemotherapy (HIPEC) to treat patients with locally advanced gastric cancer. This prospective cohort study aims to evaluate the 3-year disease-free survival as the main outcome, along with secondary goals such as major pathological response, safety, progression-free survival, overall survival, and treatment-related adverse events. Participants will receive one of two treatment approaches: the exposure group will be treated with Tislelizumab plus SOX chemotherapy combined with HIPEC, while the observation group will receive SOX chemotherapy combined with HIPEC. The SOX regimen includes S-1 oral dosing based on body surface area for 14 days every 3 weeks and intravenous oxaliplatin on day 1 for three cycles. Tislelizumab is administered intravenously at 200 mg on day 1 every 3 weeks for three cycles. The HIPEC treatment uses docetaxel on days 1 and 3. After treatment, patients undergo surgical exploration and may have surgery plus additional HIPEC if eligible. A multidisciplinary team will guide further treatment decisions if surgery is not possible or if the disease progresses. Throughout the study, participants will be closely monitored with clinical assessments, laboratory tests, and imaging to evaluate treatment response and safety. Researchers will track disease-free survival over three years and document adverse reactions during and after treatment. Participants must be willing to comply with study visits, provide blood and tissue samples, and follow contraception requirements, with a total follow-up of at least three years to assess long-term outcomes.
CONDITIONS
Official Title
A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed Her-2 negative gastric adenocarcinoma, with no prior chemotherapy, radiotherapy, or other anti-cancer treatments before the study
- Age between 18 to 80 years old with ECOG performance status 0 or 1
- Cancer staging T4aNxM0 without obstruction, perforation, or bleeding risk
- Adequate bone marrow function: white blood cells 3x10^9/L, neutrophils 1.5x10^9/L, platelets 100x10^9/L, hemoglobin 90 g/L
- Adequate organ function: AST and ALT 2.5 times upper normal limit, total bilirubin 1.5 times upper normal limit, creatinine 1.5 times upper normal limit or creatinine clearance 50 mL/min
- Coagulation within normal limits: INR, PT, and APTT 1.5 times upper normal limit
- Urine protein less than 2+, or if 2+ then 24-hour urine protein 1 g
- Consent to provide blood and tissue samples
- Expected survival longer than 3 months
- Female participants agree to strict contraception; male participants with partners of childbearing potential agree to use effective contraception
- Willing and able to comply with study visits, treatments, and procedures
You will not qualify if you...
- Participation in another drug clinical trial within the last month
- Prior anti-cancer treatments other than study medications, except limited palliative radiation
- Previous use of similar chemotherapy drugs or immune checkpoint inhibitors
- Presence of metastatic lesions in liver, lungs, lymph nodes, bones, brain, adrenal glands, or pelvic and abdominal cavity
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea within 6 months before enrollment
- Other untreated or concurrent tumors except certain cured or superficial tumors
- Symptomatic meningiomas
- History of active or refractory autoimmune diseases
- Use of systemic corticosteroids or immunosuppressive therapy within 14 days before enrollment, with some exceptions
- History of HIV or active hepatitis B or C infections
- Persistent infections above Grade 2 severity
- Significant cardiac disease including heart failure above NYHA Class II, active coronary artery disease, arrhythmias needing treatment beyond beta-blockers or digoxin, unstable angina, recent myocardial infarction complications
- Renal failure requiring dialysis
- Need for epilepsy medications
- History of organ transplantation
- Allergy or suspected allergy to study drugs
- Pregnant or breastfeeding women
- Major surgery or trauma within 4 weeks before recruitment
- Vaccination within 4 weeks before enrollment
- Investigator deems participant unsuitable for the study
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Trial Site Locations
Total: 2 locations
1
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, China, 400038
Actively Recruiting
2
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, China, 400084
Not Yet Recruiting
Research Team
Y
Yan Shi, doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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