Actively Recruiting
Conversion Therapy Plus Surgery and Radiotherapy for Retroperitoneal Nodal Metastases in Gastric Cancer
Led by Jinbo Yue · Updated on 2026-05-01
54
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, multicenter phase II clinical trial evaluating the efficacy and safety of conversion therapy combined with radical gastrectomy and adjuvant radiotherapy targeting para-aortic (station 16) lymph nodes in patients with gastric adenocarcinoma and isolated station 16 nodal metastases. Eligible participants must have no evidence of peritoneal dissemination, visceral metastases, or non-regional lymphatic spread. Based on PD-L1 combined positive score (CPS), patients in the experimental arm will receive systemic therapy with SOX (S-1 plus oxaliplatin) with or without a PD-1 inhibitor, followed by D2 gastrectomy and postoperative adjuvant SOX chemotherapy, then intensity-modulated radiotherapy (IMRT) to the para-aortic region. The control arm will receive standard chemotherapy with CAPEOX or SOX, with or without immunotherapy, according to CPS status. The primary endpoint is progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. This study aims to explore whether the addition of locoregional treatment to systemic therapy improves long-term outcomes in this select patient population.
CONDITIONS
Official 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 blood, liver, and kidney function
- Ability to provide tumor tissue for biomarker studies
- Willingness and ability to sign informed consent
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the 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
- Prior systemic anti-tumor therapy
- Prior malignancy within 3 years except certain skin or in situ cancers
- Prior PD-1, PD-L1, or CTLA-4 immunotherapy
- Participation in another interventional trial within 4 weeks
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Uncontrolled infection, hepatitis B, C, or HIV
- Brain metastases or carcinomatous meningitis
- Uncontrolled heart disease including unstable angina or recent heart attack
- Interstitial lung disease or uncontrolled lung disorder
- Uncontrolled diabetes with fasting blood glucose over 10 mmol/L
- Pregnancy or breastfeeding
- Major surgery within 4 weeks before randomization
- Any other condition that may interfere with study compliance or increase risk as judged by the investigator
AI-Screening
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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
CONTACT
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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