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Trial 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
NCT ID:
NCT05699655
Condition:
Immunotherapy Gastrict Cancer
Conditions: Official terms:
Stomach Neoplasms
Oxaliplatin
Apatinib
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
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.
Arm group label:
Tislelizumab combined with apatinib and oxaliplatin plus S1
Intervention type:
Drug
Intervention name:
apatinib
Description:
Participants will receive apatinib, 250mg, qd，every 3 weeks for 3 weeks
Arm group label:
Tislelizumab combined with apatinib and oxaliplatin plus S1
Intervention type:
Drug
Intervention name:
oxaliplatin
Description:
Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
Arm group label:
Tislelizumab combined with apatinib and oxaliplatin plus S1
Arm group label:
oxaliplatin plus S1
Intervention type:
Drug
Intervention name:
S-1
Description:
Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.
Arm group label:
Tislelizumab combined with apatinib and oxaliplatin plus S1
Arm group label:
oxaliplatin plus S1
Summary:
To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib
mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian cancer hospital
Address:
City:
Fuzhou
Zip:
350500
Country:
China
Status:
Recruiting
Contact:
Last name:
chen L chuan, bachelor
Phone:
13905022862
Phone ext:
86
Email:
luchuanchen@sina.cn
Start date:
May 10, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05699655
