Combining immunotherapy and chemotherapy for advanced gastric cancer
Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
This study is testing if combining a new immune treatment with chemotherapy can help people with advanced gastric cancer feel better and improve their chances of recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Tislelizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06451211 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of combining immunotherapy with chemotherapy in patients diagnosed with Borrmann type 4 or large type 3 gastric cancer. Participants will receive the anti-PD-1 inhibitor Tislelizumab along with platinum-based chemotherapy regimens in a 3-week cycle, followed by a radical surgical operation after completing six cycles of treatment. The study focuses on patients with specific histological confirmations and staging of gastric adenocarcinoma, ensuring a targeted approach to this rare cancer type.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-70 with histologically confirmed advanced gastric adenocarcinoma and specific tumor characteristics.
Not a fit: Patients with peritoneal metastasis or those who have received prior anti-tumor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced gastric cancer.
How similar studies have performed: While similar approaches have been explored, this specific combination for this rare gastric cancer type is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Haibo Qiu, MD, Ph.D — Sun Yat-sen University
- Study coordinator: Haibo Qiu, MD, Ph.D
- Email: qiuhb@sysucc.org.cn
- Phone: 020-87343910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.