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

Phase 2

Recruiting

• Conditions: Stomach Neoplasms; Gastric Cancer; Linitis Plastica of Stomach
• Interventions: Drug: Tislelizumab; Drug: Oxaliplatin; Drug: S-1; Drug: Capecitabine

• Registration Number: NCT06451211
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-05-17
• Study First Submitted: 2024-05-25
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-08
• Last Update Submitted: 2024-06-08
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2024-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab + SOX/XELOX	Oxaliplatin	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).
Tislelizumab + SOX/XELOX	Tislelizumab	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).
Tislelizumab + SOX/XELOX	Capecitabine	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).
Tislelizumab + SOX/XELOX	S-1	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).

Primary Outcome Measures

Name	Time	Method
MPR	up to 2 years	Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China