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

NCT06451211 | Recruiting Phase 2

• 1 other identifier: 2022-FXY-203
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms; Gastric Cancer; Linitis Plastica of Stomach

Outcome Measures

Primary Outcomes (1)

• MPR

  Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy

  up to 2 years

Secondary Outcomes (5)

• Adverse Events

  up to 2 years

• Incidence of surgical complications

  up to 2 years

• Rate of R0 resection

  up to 2 years

• OS

  up to 5 years

• DFS

  up to 5 years

Study Arms (1)

Tislelizumab + SOX/XELOX

EXPERIMENTAL

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

Interventions

Tislelizumab DRUG

Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants

Tislelizumab + SOX/XELOX

Oxaliplatin DRUG

Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants

Tislelizumab + SOX/XELOX

S-1 DRUG

S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants

Tislelizumab + SOX/XELOX

Capecitabine DRUG

Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants

Tislelizumab + SOX/XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510010, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

tislelizumab; Oxaliplatin; S 1 (combination); Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Haibo Qiu, MD, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haibo Qiu, MD, Ph.D

CONTACT

020-87343910; qiuhb@sysucc.org.cn

Chao Ding, MD, Ph.D

CONTACT

020-87343123; dingchao@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: June 11, 2024
• Study Start: May 17, 2023
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

CN (1)