Actively Recruiting
A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer with SOX Plus Tislelizumab Combined with HIPEC
Led by Southwest Hospital, China · Updated on 2025-01-07
122
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the effectiveness and safety of combining Tislelizumab with the SOX chemotherapy regimen and HIPEC treatment in patients with locally advanced gastric cancer. The study focuses on outcomes like 3-year disease-free survival and major pathological response, along with other measures such as safety, pathological complete response, progression-free survival, tumor regression grade, overall survival, and treatment-related adverse reactions. It includes patients with newly diagnosed Her-2 negative gastric adenocarcinoma who have not received prior cancer treatments. Participants will be divided into two groups: one receiving SOX plus Tislelizumab combined with HIPEC, and the other receiving SOX combined with HIPEC alone. Treatments involve cycles of SOX chemotherapy with dosing based on body surface area, Tislelizumab given intravenously every three weeks for three cycles, and HIPEC with Docetaxel administered on specific days. Depending on their response, patients may undergo surgery and additional HIPEC. Those who cannot have surgery or whose disease progresses will have their treatment plans discussed by a multidisciplinary team. During the study, participants will undergo planned visits for treatment administration, laboratory tests, and evaluations. Researchers will monitor disease status, treatment response, and adverse events through clinical assessments and sample collection. The main outcome is the 3-year disease-free survival, with other outcomes tracked over time. The total participation period includes treatment cycles and follow-up assessments to evaluate safety and efficacy.
CONDITIONS
Brief 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
- Age between 18 to 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Tumor staging T4aNxM0 without obstruction, perforation, or bleeding risk
- Good bone marrow reserve with specific blood count thresholds
- Good organ function within specified biochemical limits
- International normalized ratio (INR) and coagulation times within defined limits
- Urine protein less than 2+, or 24-hour urine protein quantification less than or equal to 1g if proteinuria is 2+
- Consent to provide blood and tissue samples
- Expected survival longer than 3 months
- Females agree to strict contraception; males with partners of childbearing potential agree to effective contraception
- Voluntarily sign informed consent and comply with study visits, treatments, and tests
You will not qualify if you...
- Participation in any other drug clinical trial within the last month
- Any prior anti-cancer treatments except for allowed palliative radiation
- Prior use of similar chemotherapy drugs or immune checkpoint inhibitors
- Presence of metastatic lesions in specific organs or lymph nodes
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea within 6 months
- Untreated or concurrent tumors except certain cured or superficial types
- Symptomatic meningiomas
- History of active or refractory autoimmune diseases
- Recent use of corticosteroids or systemic immunosuppressive therapy beyond specified allowances
- History of HIV or active hepatitis B/C infection
- Persistent infections higher than Grade 2
- Active or significant cardiac diseases including specific heart conditions
- Renal failure requiring dialysis
- Need for epilepsy medication
- History of organ transplantation
- Allergy to study medications or similar drugs
- Pregnancy or breastfeeding
- Major surgery or significant trauma within 4 weeks prior to recruitment
- Recent vaccination within 4 weeks prior to enrollment
- Any condition deemed unsuitable by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks (3 cycles of 3 weeks each)
Participants receive Tislelizumab and SOX chemotherapy over three cycles combined with HIPEC treatments.
3 treatment cycles with visits every 3 weeks
Duration - 3 years
Participants are monitored for disease-free survival and response over 3 years after treatment.
Periodic follow-up visits over 3 years
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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