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NCT05699655 | Recruiting | Immunotherapy Gastrict Cancer

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
Sponsor:

Fujian Cancer Hospital

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

Immunotherapy Gastric Cancer

Intervention/treatment

Tislelizumab

apatinib

oxaliplatin

S-1

Phase

Phase 2

Phase 3

Study Type : Interventional
Estimated Enrollment : 130 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : 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: Randomized Control, Open, Multicenter Trial-2 (TAOS-3B-Trial-2)
Actual Study Start Date : May 10, 2023
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : April 1, 2027
Arm Intervention/treatment

Experimental: Tislelizumab combined with apatinib and oxaliplatin plus S1

Other: Tislelizumab

Drug: apatinib

Drug: oxaliplatin

Active Comparator: oxaliplatin plus S1

Friend: S-1

Drug: oxaliplatin

Friend: S-1
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
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

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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

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Locations

Recruiting

China, Fujian

Fujian cancer hospital

F U axis, Fujian, China, 350500