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
Recruiting now · Phase 2/Phase 3
Conditions studied: Immunotherapy Gastrict Cancer
In brief
To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
Key facts
- Study ID
- NCT05699655
- Run by
- Fujian Cancer Hospital
- People needed
- 130
- Starts
- 2023-05-10
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2024-05-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 18-70 years of age.
- 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.
- Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.
- ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores.
- No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
- Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
- The expected survival time is more than 6 months.
- 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.
You may not qualify if…
- 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).
- 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.
- 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).
- A history of immunodeficiency, including HIV testing positive.
- 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.
- Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
- HER2 positive is known.
- Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
Where it is running
- Fujian cancer hospital — Fuzhou, Fujian, China (enrolling)
Full record on ClinicalTrials.gov
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