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

NCT06284746 | Recruiting Phase 2

• 1 other identifier: 301Qiaoz
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Locally Advanced Gastric Carcinoma; HER2 Negative; Efficacy; Safety

Outcome Measures

Primary Outcomes (2)

• 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.

  Less than 20 months

• 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.

  Less than 20 months

Secondary Outcomes (4)

• Disease-free survival（DFS）

  Less than 20 months

• Overall survival（OS）

  Less than 20 months

• Major Pathologic Response（MPR）

  Less than 20 months

• The incidence of adverse events during treatment

  Less than 20 months

Study Arms (2)

Tirelizumab combined with neoadjuvant chemotherapy

EXPERIMENTAL

Four 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.

Drug: Tirolizumab+SOX/XELOX

standard chemotherapy

ACTIVE COMPARATOR

Four cycles of standard chemotherapy regimen (SOX/XELOX regimen) were administered before and after surgery.

Drug: SOX/XELOX

Interventions

Tirolizumab+SOX/XELOX DRUG

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.

Tirelizumab combined with neoadjuvant chemotherapy

SOX/XELOX DRUG

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.

standard chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lin Chen: lead

Study Sites (1)

General Surgery Institute, China PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 39035212 BACKGROUND

• 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

  BACKGROUND

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

  PMID: 35323331 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25941355 BACKGROUND

• 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.

  PMID: 35030335 BACKGROUND

• 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.

  PMID: 29637937 BACKGROUND

• 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.

  PMID: 30464684 BACKGROUND

• 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.

  PMID: 28881921 BACKGROUND

• 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.

  PMID: 33538338 RESULT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 29, 2024
• Study Start: October 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: July 30, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

CN (1)