Locally Advanced Gastric AdenocarcinomaPhase 2NCT05507658
Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma
A Phase 2 study testing Tislelizumab combined with Oxaliplatin and Capecitabine in people with Locally Advanced Gastric Adenocarcinoma, run by Xijing Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Gastric Adenocarcinoma
- What is being tested?
- Tislelizumab combined with Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2022to 10 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent;
- Aged 18-80 (including 18 and 80), both sexes;
- ECOG score ≤1;
- Biopsy histologically confirmed adenocarcinoma (including Lauren grade);
- cT3-4a N+ M0 G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced CT (PET/CT), MRI or diagnostic laparoscopy;
Who cannot join
- Histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified carcinoma;
- Patients with HER2-positive status are excluded;
- Patients with distant metastases other than primary gastric cancer (any M1 stage);
- Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy);
- Patients who can not undergo radical surgical resection (D2 radical resection);
- Previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy and hormone therapy);
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- Previously received immunological drugs such as PD-1/PD-L1, CTLA-4 or other immunological or molecular targeted therapies;
- When virological testing prior to screening showed any of the following:
- patients with active hepatitis (HBV DNA≥1*103 copies or ≥200IU/mL);
- Anti - HCV positive;
- HIV positive;
- Patients or their families refused to sign this informed consent form to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Locally Advanced Gastric Adenocarcinoma
- Being tested
- Tislelizumab combined with Oxaliplatin and Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab combined with Oxaliplatin and CapecitabineDrug
Drugs:
- Tistelizumab 200mg, iv.gtt, D1, Q3W;
- Chemotherapy (XELOX) : oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W.
Neoadjuvant therapy:
- Tislelizumab combined with XELOX, Q3W, for 2~3 cycles;
- D2 radical gastrectomy after neoadjuvant therapy.
Adjuvant therapy:
- From 4 to 8 weeks after surgery, the treatment dose was the same as above;
- Patients who achieved MPR and non-MPR on pathological evaluation were treated with tirelizumab +XELOX 3~8 cycles;
- Tumor evaluation performed every 3 cycles;
- The maximum duration of adjuvant therapy was not more than 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with XELOX | Experimental | 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. Receives: Drug: Tislelizumab combined with Oxaliplatin and Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate(MPR)
Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time.
Measured: 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 outcomes (3)
Pathological complete response rate(pCR)
Pathological complete response
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
R0 resection rate
Rate of microscopically margin-negative resection
Measured: 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
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.
Measured: Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start18 Jul 2022
- Primary completion2 Jul 2023
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507658
- Sponsor's protocol ID
- Gang Ji -1
- Status last verified
- Mar 2025
- First submitted
- 17 Aug 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma: A Single-center, Single-arm, Phase Ⅱ Study
- ClinicalTrials.gov ID
- NCT05507658
- Acronym / sponsor ID
- Gang Ji -1
- Conditions
- Locally Advanced Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with XELOX | Experimental | Drug: Tislelizumab combined with Oxaliplatin and Capecitabine1. 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily sign the informed consent;
- Aged 18-80 (including 18 and 80), both sexes;
- ECOG score ≤1;
- Biopsy histologically confirmed adenocarcinoma (including Lauren grade);
- cT3-4a N+ M0 G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced CT (PET/CT), MRI or diagnostic laparoscopy;
Key exclusion criteria (12 listed)
- Histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified carcinoma;
- Patients with HER2-positive status are excluded;
- Patients with distant metastases other than primary gastric cancer (any M1 stage);
- Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy);
- Patients who can not undergo radical surgical resection (D2 radical resection);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab combined with Oxaliplatin and CapecitabineDrugs: 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. | Drug | Tislelizumab combined with XELOX |
Primary outcome
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.
3 secondary outcomes
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.
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.
TRAEs and postoperative complications
Time frame: Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab combined with Oxaliplatin and Capecitabine in people with Locally Advanced Gastric Adenocarcinoma, run by Xijing Hospital 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 28 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.