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NCT Number: 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

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fujian cancer hospital

Fuzhou, Fujian, 350500, China

Location status: Recruiting

Location contact

chen L chuan, bachelor

CONTACT

[email protected]

13905022862 ext. 86

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tislelizumab

Drug

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.

apatinib

Drug

Participants will receive apatinib, 250mg, qd,every 3 weeks for 3 weeks

Oxaliplatin

Drug

Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.

S-1

Drug

Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.

Primary outcomes

  1. Pathological complete response

    Time frame: 4 weeks after surgery

    Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

Secondary outcomes

  1. Major pathological response

    Time frame: 4 weeks after surgery

    Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

  2. Objective Response Rate (ORR)

    Time frame: At the end of Cycle 3 (each cycle is 21 days)]

    Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor

Study contacts

Contact information is provided by the study sponsor or research team.

Ye Z sheng, Doctor of Medicine

CONTACT

[email protected]

13950203076 ext. 86

chen lu chuan, bachelor

CONTACT

[email protected]

13905022862 ext. 86

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jan 26, 2023
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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