Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma

November 23, 2025 updated by: Xijing Hospital

Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma: A Single-center, Single-arm, Phase Ⅱ Study

The effective treatment of G/GEJ adenocarcinoma has always been a research hotspot in academia. In recent years, mainstream studies have shown that the treatment mode of G/GEJ adenocarcinoma has changed from single surgery mode in the past, to multi-disciplinary comprehensive treatment mode for now, which is based on surgery. Several studies indicate that for most late-stage G/GEJ adenocarcinoma, the neoadjuvant treatment model can further enhance the survival rates and prognosis of patients, compared with the combination of standard radical resection and postoperative adjuvant chemotherapy. According to The Chinese Society of Clinical Oncology (CSCO): clinical guidelines for the diagnosis and treatment of gastric cancer (Wang et al , 2021), neoadjuvant therapy and adjuvant therapy are recommended for patients with G/GEJ adenocarcinoma. However, there is still a lack of unified standards and norms for precise preoperative staging of gastric cancer, applicable population of neoadjuvant along with adjuvant therapy, and the selection of treatment regimens. Therefore, this project is aimed to carry out a single-arm, open-label, phase II clinical trial to administer tirelizumab plus XELOX for neoadjuvant management of patients diagnosed with resectable gastroesophageal junction or stomach cancer, and further explore the safety and therapeutic effect of chemotherapy together with tirelizumab in the neoadjuvant period of G/GEJ adenocarcinoma, eventually, providing a new option for the neoadjuvant treatment of G/GEJ adenocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Xijing Hospital of Digestive Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily sign the informed consent;
  2. Aged 18-80 (including 18 and 80), both sexes;
  3. ECOG score ≤1;
  4. Biopsy histologically confirmed adenocarcinoma (including Lauren grade);
  5. cT3-4a N+ M0 G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced CT (PET/CT), MRI or diagnostic laparoscopy;

Exclusion Criteria:

  1. Histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified carcinoma;
  2. Patients with HER2-positive status are excluded;
  3. Patients with distant metastases other than primary gastric cancer (any M1 stage);
  4. Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy);
  5. Patients who can not undergo radical surgical resection (D2 radical resection);
  6. Previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy and hormone therapy);
  7. Previously received immunological drugs such as PD-1/PD-L1, CTLA-4 or other immunological or molecular targeted therapies;

  8. When virological testing prior to screening showed any of the following:

    1. patients with active hepatitis (HBV DNA≥1*103 copies or ≥200IU/mL);
    2. Anti - HCV positive;
    3. HIV positive;
  9. Patients or their families refused to sign this informed consent form to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tislelizumab combined with XELOX
  1. Tirelizumab 200mg, iv.gtt, D1, Q3W;
  2. Chemotherapy:

Oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W.
Drug: Tislelizumab combined with Oxaliplatin and Capecitabine

Drugs:

  1. Tistelizumab 200mg, iv.gtt, D1, Q3W;
  2. Chemotherapy (XELOX) : oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W.

Neoadjuvant therapy:

  1. Tislelizumab combined with XELOX, Q3W, for 2~3 cycles;
  2. D2 radical gastrectomy after neoadjuvant therapy.

Adjuvant therapy:

  1. From 4 to 8 weeks after surgery, the treatment dose was the same as above;
  2. Patients who achieved MPR and non-MPR on pathological evaluation were treated with tirelizumab +XELOX 3~8 cycles;
  3. Tumor evaluation performed every 3 cycles;
  4. The maximum duration of adjuvant therapy was not more than 8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major pathological response rate(MPR)
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years
Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time.
From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Rate of microscopically margin-negative resection
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
TRAEs and postoperative complications
Time Frame: Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.
Including TRAEs and postoperative complications Complications refer to the occurrence of another or several diseases related to the therapeutic behavior of this disease during the treatment of a certain disease.
Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.
Pathological complete response rate(pCR)
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Pathological complete response
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2022

Primary Completion (Actual)

July 2, 2023

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gang Ji -1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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