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AzTrials

Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT07408609

Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Low Dose Radiotherapy Combined with Tislelizumab and Chemotherapy, Chemotherapeutic Agent and low-dose radiotherapy in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Jiangsu Cancer Institute & Hospital 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

This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Low Dose Radiotherapy Combined with Tislelizumab and Chemotherapy, Chemotherapeutic Agent and low-dose radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteChina
Study dates
14 May 2026to 20 Feb 2031
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Voluntary participation with written informed consent obtained; 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert type II/III) by endoscopic biopsy (pathology from outside institutions must be reviewed by the study center); 3. Staged as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition, based on endoscopy and imaging (CT, MRI, or PET-CT); 4. Age ≥20 and ≤80 years, male or female; ECOG performance status of 0-1; 5. Presence of measurable and/or non-measurable disease per RECIST v1.1; 6.No prior systemic antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational agents; Adequate organ function (no blood products or growth factors within 2 weeks prior to screening); 7. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to first dosing and agree to use effective contraception during the study and for 5 months after the last dose; men with partners of childbearing potential must use effective contraception during the study and for 7 months after the last dose.

Who cannot join

  • History of surgery for gastric or gastroesophageal junction tumors;
  • Prior history of fistula formation caused by invasion of the primary tumor; 3.High risk of gastrointestinal bleeding or perforation;
  • 4.Poor nutritional status, defined as BMI <18.5 kg/m² or PG-SGA score ≥9; 5. Major surgery or severe trauma within 4 weeks prior to first study drug administration; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Prior or ongoing treatment with anti-PD-1/PD-L1 antibodies, chemotherapy, radiotherapy, or targeted therapy; 7. Use of any investigational drug within 4 weeks prior to first study drug administration; Requirement for systemic corticosteroids; 8. Prior receipt of antitumor vaccines or live vaccines within 4 weeks before first study drug administration; 9. Active autoimmune disease or history of autoimmune disease; 10.History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, solid organ transplantation, or allogeneic bone marrow transplantation; 11.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 12.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 13.Severe infection (CTCAE grade >2) within 4 weeks prior to treatment, including infections requiring hospitalization; evidence of active pulmonary infection at baseline imaging or infections requiring antibiotics within 2 weeks prior to enrollment (prophylactic antibiotics excluded); 14.History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 15.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 16.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 17.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 18.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 19.Severe infection (CTCAE grade >2) within 4 weeks prior to treatment; History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 20.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 21.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 22.Grade >1 abnormalities in serum sodium, potassium, or calcium within 2 weeks prior to enrollment that cannot be corrected with treatment.

Trial locations and contacts

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

Gang Li, PhD. MD. contact

+8618351992292

Ligang@njmu.edu.cn

China1 site, 1 recruiting
  • Jiangsu Cancer Institute & Hospital

    Nanjing, Jiangsu, 210009

    Gang Li, PhD. MD., +8618351992292, Ligang@njmu.edu.cn

    Gang Li, PhD. MD.

    Recruiting

Other trials in China

About this study

Official title: A Phase II Multicenter Randomized Controlled Trial of Perioperative Chemotherapy Combined With Low-Dose Radiotherapy and Tislelizumab Versus Chemotherapy Alone in Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to compare the efficacy and safety of perioperative chemotherapy combined with low-dose radiotherapy and tislelizumab versus perioperative chemotherapy alone in this patient population.

Being tested
Low Dose Radiotherapy Combined with Tislelizumab and Chemotherapy, Chemotherapeutic Agent, low-dose radiotherapy

What participants receive

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

  • Low Dose Radiotherapy Combined with Tislelizumab and ChemotherapyDrug

    Chemotherapy: Oxaliplatin 130 mg/m² on days 1 and 22 plus capecitabine 1000 mg/m² twice daily on days 1-14, for a total of 3 cycles.Tislelizumab: 200 mg administered concurrently with chemotherapy on days 1 and 22 via intravenous infusion, for a total of 3 cycles. Low Dose Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.

  • Chemotherapeutic AgentDrug

    Chemotherapy: Oxaliplatin 130 mg/m² on days 1 and 22 plus capecitabine 1000 mg/m² twice daily on days 1-14, for a total of 3 cycles.

  • low-dose radiotherapyDevice

    Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.

Study groups in NCT07408609
Study groupRoleWhat they receive
Chemotherapy combined with TislelizumabExperimentalNot described
Receives: Drug: Low Dose Radiotherapy Combined with Tislelizumab and Chemotherapy; Device: low-dose radiotherapy
ChemotherapyActive comparatorNot described
Receives: Drug: Chemotherapeutic Agent

What is being measured

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

  1. Pathological Complete Response (pCR) Rate (ITT Population)

    The pathological complete response (pCR) rate is defined as the proportion of patients in the intention-to-treat (ITT) population who achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.

    Measured: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.

Secondary outcomes (4)
  1. Pathological Complete Response (pCR) Rate (Surgical Population)

    The pathological complete response (pCR) rate in the surgical population is defined as the proportion of patients who undergo surgical resection and achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.

    Measured: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.

  2. R0 Resection Rate

    The R0 resection rate is defined as the proportion of patients who undergo surgical resection and achieve microscopically margin-negative resection (R0). R0 resection is defined as no residual tumor at the resection margins on histopathological examination of the surgical specimen, as assessed according to standard pathological criteria.

    Measured: At the time of surgery, based on pathological evaluation of the resected surgical specimen.

  3. Event-Free Survival (EFS)

    Event-free survival (EFS) is defined as the time from randomization (or from treatment initiation in single-arm studies) to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence after surgery, or death from any cause. Patients who do not experience any of these events at the time of analysis will be censored at the date of the last disease assessment.

    Measured: From the date of randomization until the occurrence of disease progression, recurrence, death, or end of follow-up, whichever occurs first, assessed up 60 months.

  4. Overall Survival (OS)

    Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last follow-up.

    Measured: From the date of randomization until death from any cause or end of follow-up, whichever occurs first, assessed up to 60 months.

Timeline

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

  1. First posted13 Feb 2026
  2. Study start14 May 2026
  3. Primary completion20 Feb 2029 (estimated)
  4. Study completion20 Feb 2031 (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
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408609
Sponsor's protocol ID
GAS-Jiangsu04
Status last verified
Nov 2026
First submitted
6 Feb 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Dose Radiotherapy Combined with Tislelizumab and Chemotherapy, Chemotherapeutic Agent and low-dose radiotherapy in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Jiangsu Cancer Institute & 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 1 inclusion and 3 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 6 Nov 2026. 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 Gang Li, PhD. MD. (+8618351992292, Ligang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) Rate (ITT Population) (time frame: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.). 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 6 Nov 2026.

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