Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer
Study Details
Study Description
Brief Summary
To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tislelizumab combined with apatinib and oxaliplatin plus S1
|
Drug: Tislelizumab
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 4 cycles. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.
Drug: apatinib
Participants will receive apatinib, 250mg, qd，every 3 weeks for 3 weeks
Drug: oxaliplatin
Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
Drug: S-1
Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.
|
| Active Comparator: oxaliplatin plus S1
|
Drug: oxaliplatin
Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
Drug: S-1
Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.
|
Outcome Measures
Primary Outcome Measures
- Pathological complete response [4 weeks after surgery]
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Secondary Outcome Measures
- Major pathological response [4 weeks after surgery]
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
- Objective Response Rate (ORR) [At the end of Cycle 3 (each cycle is 21 days)]]
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18-70 years of age.
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Histologically confirmed gastric adenocarcinoma was diagnosed in patients with locally advanced gastric cancer with tumor volume >5cm Borrmann III, Borrmann IV and BulkyN according to AJCC Version 8.
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Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.
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ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores.
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No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
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Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
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The expected survival time is more than 6 months.
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For women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
Exclusion Criteria:
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Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
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Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed，if it was still positive after reexamination, gastroscopy was required.
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Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
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A history of immunodeficiency, including HIV testing positive.
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Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
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Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
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HER2 positive is known.
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Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAOS-3B Trial 2