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Locally Advanced Gastric CarcinomaPhase 2NCT06284746

Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer

A Phase 2 study testing Tirolizumab+SOX/XELOX and SOX/XELOX in people with Locally Advanced Gastric Carcinoma and HER2 Negative, run by Lin Chen at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tirolizumab+SOX/XELOX and SOX/XELOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Oct 2023to 30 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • The subjects voluntarily joined this study and signed an informed consent form
  • Locally advanced gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology as HER-2 negative (cT2-4N+M0 Phase II-III)
  • The primary lesion can be surgically removed, and the patient is willing to receive surgical treatment
  • There are measurable solid tumors (efficacy evaluation standard: RECIST 1.1)
  • Tumor evaluation should be conducted through CT scanning or MRI within 28 days before treatment
  • ECOG score 0-1
  • Life expectancy ≥ 12 months.

Who cannot join

  • Preoperative imaging examination indicates distant or peritoneal metastasis in patients
  • Subjects with any known active autoimmune disease
  • Serious cardiovascular disease
  • The serum of the subjects tested positive for HIV
  • Active hepatitis B (HbsAg positive and HBV-DNA ≥ 10 ^ 3copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, requiring antiviral treatment at the same time)
  • Known subjects with previous allergies to macromolecular protein formulations/monoclonal antibody components, or other contraindications to immunotherapy or chemotherapy
  • Have a history of alcohol, drug, or substance abuse
  • Individuals with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • General Surgery Institute, China PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Yunhe Gao, Ph.D., 86-010-66937164, gaoyunhe@301hospital.org

    Recruiting

Other trials in China

About this study

Official title: Clinical Efficacy and Safety of Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Resectable Gastric Cancer

This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.

Being tested
Tirolizumab+SOX/XELOX, SOX/XELOX

What participants receive

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

  • Tirolizumab+SOX/XELOXDrug

    Tirolizumab combined with chemotherapy(SOX/XELOX) regimen. The SOX regimen consists of the drugs Tegilol (S-1) and Oxaliplatin. The XELOX regimen consists of the drugs oxaliplatin and capecitabine.

  • SOX/XELOXDrug

    Simple chemotherapy regimen (SOX/XELOX regimen). The SOX regimen consists of the drugs Tegilol (S-1) and Oxaliplatin. The XELOX regimen consists of the drugs oxaliplatin and capecitabine.

Study groups in NCT06284746
Study groupRoleWhat they receive
Tirelizumab combined with neoadjuvant chemotherapyExperimentalFour cycles of tirolizumab combined with SOX/XELOX neoadjuvant chemotherapy regimen before surgery, followed by laparoscopic D2 gastric cancer radical surgery, and four cycles of adjuvant chemotherapy after surgery.
Receives: Drug: Tirolizumab+SOX/XELOX
standard chemotherapyActive comparatorFour cycles of standard chemotherapy regimen (SOX/XELOX regimen) were administered before and after surgery.
Receives: Drug: SOX/XELOX

What is being measured

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

  1. Pathological complete response (pCR)

    After neoadjuvant therapy, there were no residual surviving tumor cells in the tumor bed during the pathological remission assessment of postoperative specimens.

    Measured: Less than 20 months

  2. Objective Response Rate（ORR）

    The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of complete response (CR) and partial response (PR) ratios, with ORR=CR+PR.

    Measured: Less than 20 months

Secondary outcomes (4)

  1. Disease-free survival（DFS）

    Time from randomization to disease recurrence or (for any reason) death.

    Measured: Less than 20 months

  2. Overall survival（OS）

    Time from randomization to death (for any reason)

    Measured: Less than 20 months

  3. Major Pathologic Response（MPR）

    After preoperative treatment, the number of surviving tumors decreases below the threshold that can affect clinical prognosis.

    Measured: Less than 20 months

  4. The incidence of adverse events during treatment

    Including adverse reactions related to immunotherapy and postoperative complications. Reflecting safety and tolerability.

    Measured: Less than 20 months

Timeline

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

  1. First posted29 Feb 2024
  2. Study start1 Oct 2023
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Jul 2025 (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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06284746
Sponsor's protocol ID
301Qiaoz
Status last verified
Feb 2024
First submitted
21 Feb 2024
Last updated
29 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zheng R, Zhang S, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2016. J Natl Cancer Cent. 2022 Feb 27;2(1):1-9. doi: 10.1016/j.jncc.2022.02.002. eCollection 2022 Mar.

    PubMed 39035212

  • 曹毛毛；李贺；孙殿钦；何思怡；雷林；彭绩；陈万青. 2000-2019年中国胃癌流行病学趋势分析. 中华消化外科杂志. 2021;20(01):102-109. doi:10.3760/cma.j.cn115610-20201130-00746

  • Hogner A, Moehler M. Immunotherapy in Gastric Cancer. Curr Oncol. 2022 Mar 2;29(3):1559-1574. doi: 10.3390/curroncol29030131.

    PubMed 35323331

  • Xu J, Jiang H, Pan Y, et al. LBA53 Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): First results of a randomized, double-blind, phase III study. Ann Oncol. 2021;32:S1331. doi:10.1016/j.annonc.2021.08.2133

  • Emens LA, Middleton G. The interplay of immunotherapy and chemotherapy: harnessing potential synergies. Cancer Immunol Res. 2015 May;3(5):436-43. doi: 10.1158/2326-6066.CIR-15-0064.

    PubMed 25941355

  • Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11.

    PubMed 35030335

  • King GT, Sharma P, Davis SL, Jimeno A. Immune and autoimmune-related adverse events associated with immune checkpoint inhibitors in cancer therapy. Drugs Today (Barc). 2018 Feb;54(2):103-122. doi: 10.1358/dot.2018.54.2.2776626.

    PubMed 29637937

  • Myers G. Immune-related adverse events of immune checkpoint inhibitors: a brief review. Curr Oncol. 2018 Oct;25(5):342-347. doi: 10.3747/co.25.4235. Epub 2018 Oct 31.

    PubMed 30464684

  • Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, Jordan K; ESMO Guidelines Committee. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119-iv142. doi: 10.1093/annonc/mdx225. No abstract available.

    PubMed 28881921

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirolizumab+SOX/XELOX and SOX/XELOX in people with Locally Advanced Gastric Carcinoma and HER2 Negative, run by Lin Chen 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Feb 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) (time frame: Less than 20 months). The study lists 2 primary outcomes in all. 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 NCT06284746, which also lists 10 linked publications.

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 29 Feb 2024.

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