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

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2027-04-01

Brief Summary

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

Conditions

Immunotherapy Gastrict Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab combined with apatinib and oxaliplatin plus S1

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: 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

Intervention Type: DRUG

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

oxaliplatin

Intervention Type: DRUG

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

S-1

Intervention Type: DRUG

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

oxaliplatin plus S1

Group Type: ACTIVE_COMPARATOR

oxaliplatin

Intervention Type: DRUG

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

S-1

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

apatinib

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

Intervention Type: DRUG

oxaliplatin

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

Intervention Type: DRUG

S-1

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian cancer hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

chen lu chuan, bachelor

Role: CONTACT

Luchuanchen@sina.cn

13905022862 ext. 86

Ye Z sheng, Doctor of Medicine

Role: CONTACT

flyingengel@sina.cn

13950203076 ext. 86

Facility Contacts

chen L chuan, bachelor

Role: primary

luchuanchen@sina.cn

13905022862 ext. 86

Other Identifiers

TAOS-3B Trial 2

Identifier Type: -

Identifier Source: org_study_id