Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

Gastric Cancer Clinical Trial

— Neo-ICEBOAT  

Official title:

Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451211
• Other study ID #: 2022-FXY-203
• Status: Recruiting
• Phase: Phase 2
• Start date: May 17, 2023
• Est. completion date: November 2027

Study information

• Verified date: June 2024
• Source: Sun Yat-sen University
• Contact: Haibo Qiu, MD, Ph.D
• Phone: 020-87343910
• Email: qiuhb[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: November 2027
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Linitis Plastica
• Stomach Neoplasms

Intervention

Drug:
• Tislelizumab
Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants
• Oxaliplatin
Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants
• S-1
S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants
• Capecitabine
Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPR	Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy	up to 2 years
Secondary	Adverse Events		up to 2 years
Secondary	Incidence of surgical complications		up to 2 years
Secondary	Rate of R0 resection		up to 2 years
Secondary	OS	3-year overal survival	up to 5 years
Secondary	DFS	3-year disease-free survival	up to 5 years