Actively Recruiting
A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer
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
The clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating locally advanced gastric cancer. The primary and secondary objectives are as follows: To evaluate the 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated with systemic SOX chemotherapy plus Tislelizumab and HIPEC. To assess the major pathological response (MPR) in these patients. Secondary objectives include safety, pathological complete response (pCR), progression-free survival (PFS), tumor regression grade (TRG), overall survival (OS), incidence of adverse reactions during treatment, postoperative adverse reactions, and treatment efficacy. Participants will: Be willing to receive SOX plus Tislelizumab combined with HIPEC treatment (exposure group), undergo HIPEC followed by SOX and Tislelizumab to achieve stable disease (SD), partial response (PR), or complete response (CR). Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, a multidisciplinary team (MDT) discussion will follow to determine the next treatment plan. Patients with progressive disease (PD) will also have an MDT discussion to determine the subsequent treatment. Be willing to receive SOX combined with HIPEC treatment (observation group), undergo HIPEC followed by SOX to achieve SD, PR, or CR. Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, an MDT discussion will follow to determine the next treatment plan. Patients with PD will also have an MDT discussion to determine the subsequent treatment. Treatment details: SOX: S-1 dosage based on body surface area (BSA): \<1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles. Tislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles. HIPEC: Docetaxel: 120mg, day 1, day 3.
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
AI-Screening
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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
CONTACT
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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