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NCT06451211RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 11 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
53 (estimated)
First submitted
25 May 2024
Start date
17 May 2023
Primary completion date
Nov 2024
Lead sponsor
Sun Yat-sen University
NCT number
NCT06451211

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 53
  • From 17 May 2023 to the primary completion date, Nov 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous cytotoxic chemotherapy, radiotherapy or immunotherapy
  • Unable to take drugs orally

Other illness

  • History of another malignancy within the last five years;
  • Allergic to to any drug of the study regimen;

Other

  • Women who are pregnant or breastfeeding or may be pregnant

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.