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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stomach Neoplasms; Gastric Cancer; Linitis Plastica of Stomach
• Intervention / Treatment: Drug: Tislelizumab; Drug: Oxaliplatin; Drug: S-1; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Haibo Qiu, MD, Ph.D; Phone Number: 020-87343910; Email: qiuhb@sysucc.org.cn
• Study Contact Backup: Name: Chao Ding, MD, Ph.D; Phone Number: 020-87343123; Email: dingchao@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510010
      • Recruiting
      • Sun yat-sen University Cancer Center
      • Contact: Haibo Qiu; Phone Number: 020-87343910; Email: qiuhb@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tislelizumab + SOX/XELOX; 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).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPR	Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events		up to 2 years
Incidence of surgical complications		up to 2 years
Rate of R0 resection		up to 2 years
OS	3-year overal survival	up to 5 years
DFS	3-year disease-free survival	up to 5 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Haibo Qiu, MD, Ph.D, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: June 8, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 8, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma, Scirrhous; Stomach Neoplasms; Linitis Plastica; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Capecitabine; Oxaliplatin; Tislelizumab
• Other Study ID Numbers: 2022-FXY-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No