Clinical trial · Interventional
Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer
Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
NCT06451211CI-TRIAL-00077856Neo-ICEBOATrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Linitis Plastica of Stomach | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab + SOX/XELOX
- description
- Patients with borrmann type 4 or large type 3 (over 8 cm) gastric cancer, who are deemed to be surgically resectable, are treated with neoadjuvant Tislelizumab (200 mg) and oxaliplatin (150 mg) intravenously on day 1 plus capecitabine (2500 mg) or S-1 (40 mg) orally on day 1-14 in each 21-day cycle. Radical gastrectomy will be performed after 6 cycles, followed by adjuvant chemotherapy (capecitabine or S-1).
- interventionNames
- Drug: Tislelizumab
- Drug: Oxaliplatin
- Drug: S-1
- Drug: Capecitabine
Primary outcomes (1)
- measure
- MPR
- timeFrame
- up to 2 years
- description
- Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.