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Recruiting 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

Phase II / Phase III Interventional Immunotherapy Gastrict Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tislelizumab, apatinib, oxaliplatin, S-1.
Who it may be relevant to
Registry conditions: Immunotherapy Gastrict Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.

Interventions

  • 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.

Primary outcome measures

  • Pathological complete response [Time frame: 4 weeks after surgery]
Secondary outcome measures (2)
  • Major pathological response [Time frame: 4 weeks after surgery]
  • Objective Response Rate (ORR) [Time frame: At the end of Cycle 3 (each cycle is 21 days)]]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian cancer hospital — Fuzhou

Identifiers

NCT: NCT05699655 · TAOS-3B Trial 2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗