Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer

NCT ID: NCT05223088

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2024-04-30

Brief Summary

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

Conditions

Immunotherapy; Gastrict Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab combined with apatinib and oxaliplatin plus S1

Neoadjuvant immunotherapy, PD-1, plus apatinib and oxaliplatin plus S1 will be applied to patients with Borrmann IV、large Borrmann III type and Bulky N positive advanced gastric cancer before surgery.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 3-6 weeks. 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 Mesylate

Intervention Type: DRUG

Participants will receive apatinib, 250mg, qd，every 3 weeks for 2-5 weeks.

oxaliplatin

Intervention Type: DRUG

Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 3-6 weeks.

Tegafur

Intervention Type: DRUG

Participants will receive Tegafur, day 1-14 of every 3 weeks for 3-6 weeks.

Interventions

Tislelizumab

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 3-6 weeks. 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 Mesylate

Participants will receive apatinib, 250mg, qd，every 3 weeks for 2-5 weeks.

Intervention Type: DRUG

oxaliplatin

Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 3-6 weeks.

Intervention Type: DRUG

Tegafur

Participants will receive Tegafur, day 1-14 of every 3 weeks for 3-6 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
• the main organ function is normal, which should meet the following criteria:

1. HB≥ 9g/dL

2. ANC≥1.5×109/L

3. PLT≥100×109/L

4. TBIL≤1.5 normal upper limit ULN ；or TBIL>ULN but BIL≤ULN

5. ALT and AST≤2.5 ULN（ALT or AST ≤5×ULN was allowed in patients with liver metastasis）

6. Cr≤1.5 ULN，CCR（creatinine clearance rate）≥60ml/min(Cockcroft-Gault formula)

7. Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN

8. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range.If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled;

9. The myocardial enzyme profile is within the normal range (if the investigator comprehensively determines that the simple laboratory abnormality is not clinically significant, it is allowed to be included in the group

• 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;。
• If there is a risk of conception, all subjects (both men and women) are required to use a contraceptive with an annual failure rate of less than 1% throughout the treatment period up to 120 days after the last study drug (or 180 days after the last chemotherapeutic drug)
• participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.

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, , China

Countries

China

Other Identifiers

TAOS-3B

Identifier Type: -

Identifier Source: org_study_id