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Stomach NeoplasmsPhase 2Neo-ICEBOATNCT06451211

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

A Phase 2 study testing Tislelizumab, Oxaliplatin and S-1 in people with Stomach Neoplasms and Gastric Cancer, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tislelizumab, Oxaliplatin and S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
17 May 2023to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haibo Qiu, MD, Ph.D contact

020-87343910

qiuhb@sysucc.org.cn

Chao Ding, MD, Ph.D contact

020-87343123

dingchao@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510010

    Haibo Qiu, 020-87343910, qiuhb@sysucc.org.cn

    Recruiting

Other trials in China

About this study

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

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.

Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

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

  • OxaliplatinDrug

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

  • S-1Drug

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

  • CapecitabineDrug

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

Study groups in NCT06451211
Study groupRoleWhat they receive
Tislelizumab + SOX/XELOXExperimentalPatients 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).
Receives: Drug: Tislelizumab; Drug: Oxaliplatin; Drug: S-1; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MPR

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

    Measured: up to 2 years

Secondary outcomes (5)

  1. Adverse Events

    Measured: up to 2 years

  2. Incidence of surgical complications

    Measured: up to 2 years

  3. Rate of R0 resection

    Measured: up to 2 years

  4. OS

    3-year overal survival

    Measured: up to 5 years

  5. DFS

    3-year disease-free survival

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start17 May 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06451211
Sponsor's protocol ID
2022-FXY-203
Acronym
Neo-ICEBOAT
Status last verified
Jun 2024
First submitted
25 May 2024
Last updated
11 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Oxaliplatin and S-1 in people with Stomach Neoplasms and Gastric Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haibo Qiu, MD, Ph.D (020-87343910, qiuhb@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MPR (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06451211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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