Conversion therapy with surgery and targeted para‑aortic radiotherapy for gastric cancer with retroperitoneal (station 16) lymph node spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase II trial enrolls patients with gastric adenocarcinoma who have isolated para‑aortic (station 16) lymph node metastases and no peritoneal or visceral disease. Participants are randomized 2:1 to an experimental arm that receives first‑line SOX chemotherapy (with or without a PD‑1 inhibitor based on PD‑L1 CPS), followed by D2 gastrectomy for those with disease control, then adjuvant SOX and intensity‑modulated radiotherapy to the para‑aortic basin; the control arm receives standard systemic therapy (CAPEOX or SOX ± immunotherapy) without surgery or radiotherapy. Tumor tissue, blood, and stool samples are collected at multiple time points for biomarker analyses including PD‑L1/CPS, MSI/TMB, tumor immune microenvironment profiling, and circulating immune cell subsets. The primary endpoint is progression‑free survival, with overall survival and safety as key secondary endpoints.

Why it matters

Who can join: the full rules

Inclusion:

Histologically confirmed gastric adenocarcinoma with isolated para-aortic (station 16) lymph node metastasis; pMMR or MSS subtype; ECOG performance status 0-2; Life expectancy ≥ 3 months; Adequate organ function (hematologic, hepatic, renal); Ability to provide tumor tissue for biomarker analysis; Ability to understand and willingness to sign written informed consent; Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during study and for 12 months after treatment; men with partners of childbearing potential must also agree to contraception.

Exclusion Criteria:

Evidence of visceral or peritoneal metastasis; MSI-H or dMMR subtype; HER2-positive disease (IHC 3+ or IHC 2+ with FISH positive); Prior systemic anti-tumor therapy; Prior malignancy within 3 years (except adequately treated basal cell/squamous cell carcinoma of the skin or in situ carcinoma); Prior PD-1/PD-L1/CTLA-4 therapy; Participation in another interventional trial within 4 weeks; Active autoimmune disease requiring systemic therapy within past 2 years; Uncontrolled infection, hepatitis B, C, or HIV; CNS metastases or carcinomatous meningitis; Uncontrolled cardiovascular disease (unstable angina, recent MI, NYHA III-IV heart failure, QTc ≥480 ms); Interstitial lung disease or uncontrolled pulmonary disease; Uncontrolled diabetes mellitus (FBG \>10 mmol/L); Pregnancy or breastfeeding; Major surgery within 4 weeks prior to randomization; Any other condition that may interfere with protocol compliance or increase risk as judged by the investigator.

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jinbo Yue, MD, PhD — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, MD, PhD
• Email: jbyue@sdfmu.edu.cn
• Phone: 053167626442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.