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

NCT05223088 | Completed Phase 2

• 1 other identifier: TAOS-3B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immunotherapy; Gastrict Cancer

Outcome Measures

Primary Outcomes (1)

• Total/moderate tumor regression rate under pathology

  Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell

  4 weeks after surgery

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  At the end of Cycle 3 (each cycle is 21 days)

• Overall survival (OS)

  every 3 months (up to 24 months) ]

Study Arms (1)

Tislelizumab combined with apatinib and oxaliplatin plus S1

EXPERIMENTAL

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.

Drug: Tislelizumab; Drug: Apatinib Mesylate; Drug: oxaliplatin; Drug: Tegafur

Interventions

Tislelizumab 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.

Tislelizumab combined with apatinib and oxaliplatin plus S1

Apatinib Mesylate DRUG

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

Tislelizumab combined with apatinib and oxaliplatin plus S1

oxaliplatin DRUG

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

Tislelizumab combined with apatinib and oxaliplatin plus S1

Tegafur DRUG

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

Tislelizumab combined with apatinib and oxaliplatin plus S1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• HB≥ 9g/dL
• ANC≥1.5×109/L
• PLT≥100×109/L
• TBIL≤1.5 normal upper limit ULN ；or TBIL\>ULN but BIL≤ULN
• ALT and AST≤2.5 ULN（ALT or AST ≤5×ULN was allowed in patients with liver metastasis）
• Cr≤1.5 ULN，CCR（creatinine clearance rate）≥60ml/min(Cockcroft-Gault formula)
• Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian cancer hospital

Fuzhou, China

Location

MeSH Terms

Interventions

tislelizumab; apatinib; Oxaliplatin; Tegafur

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 3, 2022
• Study Start: October 31, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

CN (1)