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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

Primary Purpose

Immunotherapy Gastrict Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
apatinib
oxaliplatin
S-1
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunotherapy Gastrict Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fujian cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tislelizumab combined with apatinib and oxaliplatin plus S1

oxaliplatin plus S1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Major pathological response
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor

Full Information

First Posted
January 17, 2023
Last Updated
June 14, 2023
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05699655
Brief 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
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunotherapy Gastrict Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab combined with apatinib and oxaliplatin plus S1
Arm Type
Experimental
Arm Title
oxaliplatin plus S1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
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
Intervention Name(s)
apatinib
Intervention Description
Participants will receive apatinib, 250mg, qd,every 3 weeks for 3 weeks
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.
Primary Outcome Measure Information:
Title
Pathological complete response
Description
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Time Frame
4 weeks after surgery
Secondary Outcome Measure Information:
Title
Major pathological response
Description
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Time Frame
4 weeks after surgery
Title
Objective Response Rate (ORR)
Description
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Time Frame
At the end of Cycle 3 (each cycle is 21 days)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chen lu chuan, bachelor
Phone
13905022862
Ext
86
Email
Luchuanchen@sina.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Z sheng, Doctor of Medicine
Phone
13950203076
Ext
86
Email
flyingengel@sina.cn
Facility Information:
Facility Name
Fujian cancer hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chen L chuan, bachelor
Phone
13905022862
Ext
86
Email
luchuanchen@sina.cn

12. IPD Sharing Statement

Learn more about this trial

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

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