Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
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

Led by Fujian Cancer Hospital · Updated on 2024-05-01

130

Participants Needed

1

Research Sites

203 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Histologically confirmed gastric adenocarcinoma with locally advanced cancer, tumor volume greater than 5 cm, Borrmann III, Borrmann IV, or Bulky N positive according to AJCC Version 8
  • Measurable lesions detected by CT or MRI according to RECIST 1.1
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • No prior surgical treatment, chemotherapy, radiotherapy, or immunotherapy for gastric cancer
  • Preoperative endoscopic exam showing no positive peritoneal implantation metastasis or exfoliated cells
  • Expected survival time longer than 6 months
  • Women of reproductive age must have a negative urine or serum pregnancy test within 3 days before first treatment; women are considered of childbearing age if at least 1 year post-menopause or have had surgical sterilization or hysterectomy
Not Eligible

You will not qualify if you...

  • Diagnosis of malignant diseases other than gastric cancer within 5 years before treatment, except certain skin cancers or carcinoma in situ
  • Significant bleeding symptoms or bleeding tendency such as gastrointestinal bleeding or hemorrhagic gastric ulcer within 3 months before enrollment
  • Positive fecal occult blood test at baseline confirmed by gastroscopy if reexamination remains positive
  • Prior use of anti-PD-1, anti-PD-L1, anti-PD-L2 drugs, or drugs targeting other T-cell receptors like CTLA-4, OX-40, CD137
  • History of immunodeficiency including HIV positive status
  • Participation in another interventional clinical study or use of another study drug or device within 4 weeks before initial dosing
  • History of cardiovascular or cerebrovascular disease with ongoing oral thrombolytic or anticoagulant treatment
  • Known HER2 positive status
  • Previous gastrointestinal perforation, abdominal abscess, recent intestinal obstruction within 3 months, or clinical/imaging signs of intestinal obstruction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fujian cancer hospital

Fuzhou, Fujian, China, 350500

Actively Recruiting

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Research Team

C

chen lu chuan, bachelor

CONTACT

Y

Ye Z sheng, Doctor of Medicine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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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 | DecenTrialz