Conversion therapy with surgery and targeted para‑aortic radiotherapy for gastric cancer with retroperitoneal (station 16) lymph node spread
A Randomized, Controlled, Multicenter Phase II Study of Conversion Therapy Combined With Surgery and Radiotherapy for Retroperitoneal Lymph Node Metastases in Gastric Cancer
This trial tests whether chemotherapy (SOX with or without a PD‑1 inhibitor), followed by D2 gastrectomy and para‑aortic radiotherapy, helps people with gastric adenocarcinoma who have only para‑aortic lymph node metastases live longer without their cancer progressing compared with standard chemotherapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07007182 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed gastric adenocarcinoma limited to isolated para‑aortic (station 16) lymph node metastasis, ECOG 0–2, adequate organ function, and no peritoneal or visceral metastases.
Not a fit: Patients with widespread metastases (visceral or peritoneal disease), MSI‑high/dMMR or HER2‑positive tumors, prior systemic anti‑tumor therapy, or poor organ function are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could convert limited para‑aortic nodal disease into potentially curative cases and prolong progression‑free and overall survival compared with chemotherapy alone.
How similar studies have performed: Previous conversion therapy series and surgical reports have suggested benefit for highly selected patients with limited nodal disease, but the randomized combination of planned D2 resection with targeted para‑aortic IMRT is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jinan, Shandong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.