Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tislelizumab, Oxaliplatin, S-1, Capecitabine.
- Who it may be relevant to
- Registry conditions: Stomach Neoplasms, Gastric Cancer, Linitis Plastica of Stomach. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
Overview
The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.
Interventions
- Drug Tislelizumab
Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants - Drug Oxaliplatin
Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants - Drug S-1
S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants - Drug Capecitabine
Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants
Primary outcome measures
- MPR [Time frame: up to 2 years]
Secondary outcome measures (5)
- Adverse Events [Time frame: up to 2 years]
- Incidence of surgical complications [Time frame: up to 2 years]
- Rate of R0 resection [Time frame: up to 2 years]
- OS [Time frame: up to 5 years]
- DFS [Time frame: up to 5 years]
Eligibility criteria
Inclusion criteria
- Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
- Males or females, aged 18-70 years;
- Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
- No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
- ECOG performance status 0 or 1;
- Sufficient organ function:
- white blood cell count > 4\*10\^9/L, neutrophil cell count > 1.5\*10\^9/L, hemoglobin > 90 g/L, platelet count > 100\*10\^9 /L
- Serum bilirubin ≤ 1.5×upper limit of normal (ULN), AST, ALT ≤ 2.5×ULN
- Creatinine ≤ 1.5 ×ULN or serum clearance > 60 ml/min
- INR and aPTT ≤ 1.5 × ULN, only for subjects not receiving anticoagulant therapy;Subjects undergoing coagulation therapy should use a stable dose
- No prior anti-tumor therapy;
- Have signed informed consent before the beginning of treatment.
Exclusion criteria
- History of another malignancy within the last five years;
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy
- Unable to take drugs orally
- Allergic to to any drug of the study regimen;
- Women who are pregnant or breastfeeding or may be pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06451211 · 2022-FXY-203