Perioperative chemo with low-dose radiotherapy and tislelizumab for locally advanced gastric/GEJ cancer
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
Run by Jiangsu Cancer Institute & Hospital · NCT07408609 · Data updated 2026-11-12
This trial tests whether adding low-dose radiotherapy and tislelizumab to perioperative chemotherapy helps people with resectable locally advanced gastric or gastroesophageal junction cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | Jiangsu Cancer Institute & Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, tislelizumab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | May 14, 2026 |
| Main results expected | February 20, 2029 |
| Study ends | February 20, 2031 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07408609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 20–80 with resectable, locally advanced Siewert type II/III gastric/GEJ adenocarcinoma, good performance status, no prior systemic therapy, and suitable organ function.
✕Probably not a fit
Patients whose tumors do not respond to the combination therapy or who experience intolerable toxicity may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized phase II study enrolling patients with resectable locally advanced gastric or GEJ adenocarcinoma. It compares perioperative chemotherapy plus low-dose radiotherapy and tislelizumab against perioperative chemotherapy alone. Eligible participants have Siewert type II/III tumors, appropriate AJCC stage, good performance status, and no prior systemic therapy. The trial will assess safety and efficacy signals to determine if the combination improves outcomes. Enrollment is limited to adults up to 80 years and requires informed consent.
Why it matters
Potential benefit: If successful, patients could have improved response rates and potentially better surgical outcomes with the combination therapy.
How similar studies have gone: Previous studies in similar perioperative strategies show variable success; this trial explores a novel combination including immunotherapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. History of surgery for gastric or gastroesophageal junction tumors; 2. 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.
Where it's running
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Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Gang Li, PhD. MD. — Jiangsu Cancer Institute & Hospital
- Study coordinator: Gang Li, PhD. MD.
- Email: Ligang@njmu.edu.cn
- Phone: +8618351992292
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.