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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Gastric Cancer; Linitis Plastica of Stomach; Stomach Neoplasms

Treatments: Drug: Tislelizumab; Drug: S-1; Drug: Capecitabine; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06451211

2022-FXY-203

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Tislelizumab + SOX/XELOX

Experimental group

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).

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

Drug: S-1

Drug: Tislelizumab