Conversion Therapy Plus Surgery and Radiotherapy for Retroperitoneal Nodal Metastases in Gastric Cancer

Launched by JINBO YUE · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with gastric cancer that has spread to specific lymph nodes near the aorta, known as station 16. The trial aims to find out if combining conversion therapy—where patients receive powerful medications to shrink their tumors—followed by surgery and targeted radiation, can improve outcomes compared to standard chemotherapy. Participants in the study will be randomly assigned to either the experimental group, which receives the new treatment approach, or the control group, which will receive standard chemotherapy with or without additional immunotherapy. The main goal is to see how long patients can remain free from disease progression.

To participate, individuals must be between 18 and 75 years old, have a confirmed diagnosis of gastric adenocarcinoma with specific lymph node involvement, and have no signs of widespread disease. They should also be in generally good health and able to provide consent. Those who join can expect to undergo treatment and monitoring for their cancer over the course of the study, with the hope of improving their treatment outcomes. It’s important to note that this trial has not started recruiting participants yet, so updates will be available in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed written informed consent before any study-specific procedure; Male or female, age 18-75 years; Histologically confirmed gastric adenocarcinoma with para-aortic (station 16) lymph node metastasis; pMMR or MSS subtype; ECOG performance status 0-2; No prior anti-tumor therapy; At least one measurable lesion according to RECIST 1.1; Tumor tissue available for biomarker analysis; Expected survival ≥3 months; Adequate organ function; Negative pregnancy test for women of childbearing potential; Use of effective contraception during study and 12 months after treatment.
• Exclusion Criteria:
• • Evidence of visceral or peritoneal metastasis; MSI-H or dMMR subtype; HER2 (++ with FISH positive or +++); Prior malignancies (except cured skin basal/squamous cell carcinoma or in situ carcinoma) within 3 years; Prior PD-1/PD-L1/CTLA-4 or similar immunotherapies; Participation in other interventional trials within 4 weeks; Systemic corticosteroid use within 7 days (except physiologic replacement); Active autoimmune disease requiring systemic treatment in past 2 years; Untreated active hepatitis B, HCV, or HIV infection; Active CNS metastases or carcinomatous meningitis; Uncontrolled hypertension, unstable angina, NYHA III-IV heart failure, QTc ≥480ms; Active interstitial lung disease, uncontrolled infections, GI obstruction; Poorly controlled diabetes (FBG \>10 mmol/L); Pregnancy or breastfeeding; Major surgery within 4 weeks before enrollment; Any condition that may interfere with protocol compliance or increase risk as judged by the investigator.