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

NCT05699655 | Recruiting Phase 2

• 1 other identifier: TAOS-3B Trial 2
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

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

  4 weeks after surgery

Secondary Outcomes (2)

• Major pathological response

  4 weeks after surgery

• Objective Response Rate (ORR)

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

Study Arms (2)

Tislelizumab combined with apatinib and oxaliplatin plus S1

EXPERIMENTAL

Drug: Tislelizumab; Drug: apatinib; Drug: oxaliplatin; Drug: S-1

oxaliplatin plus S1

ACTIVE COMPARATOR

Drug: oxaliplatin; Drug: S-1

Interventions

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.

Tislelizumab combined with apatinib and oxaliplatin plus S1

apatinib DRUG

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

Tislelizumab combined with apatinib and oxaliplatin plus S1

oxaliplatin DRUG

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

Tislelizumab combined with apatinib and oxaliplatin plus S1; oxaliplatin plus S1

S-1 DRUG

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

Tislelizumab combined with apatinib and oxaliplatin plus S1; 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.
• 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.

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, Fujian, 350500, China

RECRUITING

MeSH Terms

Interventions

tislelizumab; apatinib; Oxaliplatin; S 1 (combination)

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

chen lu chuan, bachelor

CONTACT

13905022862; Luchuanchen@sina.cn

Ye Z sheng, Doctor of Medicine

CONTACT

13950203076; flyingengel@sina.cn

Study Design

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

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: May 10, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 1, 2024

Record last verified: 2024-05

Locations

CN (1)