Actively Recruiting
Conversion Therapy Combined With Surgery and Radiotherapy for Para-Aortic Lymph Node Metastases in Gastric Adenocarcinoma: A Randomized Phase II Trial
Led by Jinbo Yue · Updated on 2026-05-01
54
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for patients with gastric adenocarcinoma who have isolated metastases to the para-aortic (station 16) lymph nodes without spread to the peritoneum, other distant organs, or non-regional lymph nodes. This is a randomized, controlled phase II study aiming to see if adding locoregional treatments like surgery and radiotherapy to systemic therapy improves long-term outcomes compared to standard chemotherapy alone. The study also explores biomarkers and immune environment features to better understand treatment responses. Participants are assigned to one of two groups based on their PD-L1 combined positive score (CPS). In the experimental group, patients with CPS 651 receive 3 cycles of SOX chemotherapy plus a PD-1 inhibitor, then undergo radical gastrectomy followed by 5 cycles of adjuvant SOX chemotherapy and intensity-modulated radiotherapy (IMRT) to the para-aortic lymph nodes with concurrent oral capecitabine or S-1 as radiosensitizers. Maintenance PD-1 inhibitor therapy continues for up to one year in these patients. Those with CPS less than 1 receive SOX alone followed by the same surgery, chemotherapy, and radiotherapy schedule. The control group receives standard chemotherapy with CAPEOX or SOX, with or without immunotherapy, but no surgery or radiotherapy. During the study, participants provide tumor tissue, blood, and fecal samples for biomarker studies. Researchers monitor treatment effects through progression-free survival at two years as the primary outcome, along with overall survival, response rates, disease control, and safety over approximately three years. Follow-up lasts for 24 months after enrollment, allowing careful assessment of long-term outcomes and adverse effects. A total of 54 patients will enroll with a planned accrual period of 18 months.
CONDITIONS
Brief Title
Conversion Therapy Plus Surgery and Radiotherapy for Retroperitoneal Nodal Metastases in Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed gastric adenocarcinoma with isolated para-aortic (station 16) lymph node metastasis
- pMMR or MSS subtype
- ECOG performance status 0-2
- Life expectancy of at least 3 months
- Adequate organ function (hematologic, hepatic, renal)
- Ability to provide tumor tissue for biomarker analysis
- Ability to understand and 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 agree to use contraception
You will not qualify if you...
- 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 treated basal cell/squamous cell skin cancer 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 including unstable angina, recent myocardial infarction, NYHA III-IV heart failure, or QTc 90 ms
- Interstitial lung disease or uncontrolled pulmonary disease
- Uncontrolled diabetes mellitus (fasting blood glucose >10 mmol/L)
- Pregnancy or breastfeeding
- Major surgery within 4 weeks prior to randomization
- Any other condition interfering with protocol compliance or increasing risk as judged by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks (3 cycles of 21 days each)
Participants receive first-line systemic conversion therapy with the SOX regimen (S-1 plus oxaliplatin), with or without a PD-1 inhibitor depending on PD-L1 CPS score, for 3 cycles before surgery.
3 visits (in-person) for each treatment cycle
Duration - Single surgical procedure with immediate recovery period
Participants with disease control after conversion therapy undergo D2 radical gastrectomy to remove gastric tumors and affected lymph nodes.
1 visit (in-person) for surgery and immediate post-operative care
Duration - Approximately 15 weeks (5 cycles of 21 days each and 25 radiation fractions)
Following surgery, participants receive 5 cycles of adjuvant SOX chemotherapy combined with para-aortic lymph node radiotherapy (IMRT) delivered concurrently with oral capecitabine or S-1 as radiosensitizers.
5 chemotherapy visits and daily radiotherapy visits over 5 weeks
Duration - Up to 12 months
Participants with PD-L1 CPS ≥1 continue maintenance PD-1 inhibitor therapy for up to 1 year or until disease progression or unacceptable toxicity.
Every 3 weeks intravenous infusion visits
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
J
Jinbo Yue, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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