Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06451211

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510010, China

Location status: Recruiting

Location contact

Haibo Qiu

CONTACT

[email protected]

020-87343910

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tislelizumab

Drug

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

Oxaliplatin

Drug

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

S-1

Drug

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

Capecitabine

Drug

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

Primary outcomes

  1. MPR

    Time frame: up to 2 years

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

Secondary outcomes

  1. Adverse Events

    Time frame: up to 2 years

  2. Incidence of surgical complications

    Time frame: up to 2 years

  3. Rate of R0 resection

    Time frame: up to 2 years

  4. OS

    Time frame: up to 5 years

    3-year overal survival

  5. DFS

    Time frame: up to 5 years

    3-year disease-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Ding, MD, Ph.D

CONTACT

[email protected]

020-87343123

Haibo Qiu, MD, Ph.D

CONTACT

[email protected]

020-87343910

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: Neo-ICEBOAT

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.