NCT05699655 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
| NCT ID | NCT05699655 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Fujian Cancer Hospital |
| Condition | Immunotherapy Gastrict Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2025-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2023-05-10 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05699655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Immunotherapy Gastrict Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05699655 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05699655 currently recruiting?
Yes, NCT05699655 is actively recruiting participants. Contact the research team at Luchuanchen@sina.cn for enrollment information.
Where is the NCT05699655 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT05699655 clinical trial?
NCT05699655 is sponsored by Fujian Cancer Hospital. The trial plans to enroll 130 participants.
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