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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

April 1, 2029

Study Completion Date

October 1, 2030

Conditions
Gastric AdenocarcinomaStomach Neoplasms
Interventions
DRUG

SOX regimen

"The SOX regimen consists of oxaliplatin 130 mg/m² IV on day 1 plus oral S-1 (tegafur/gimeracil/oteracil) 40-60 mg twice daily, taken on days 1-14 followed by 7 days off, in a 21-day cycle.~Experimental arm: 3 cycles before surgery, 5 cycles after surgery. Control arm: up to 8 cycles as standard systemic therapy."

DRUG

CAPEOX regimen

"The CAPEOX regimen consists of oxaliplatin 130 mg/m² IV on day 1 plus oral capecitabine 1000 mg/m² twice daily on days 1-14, repeated every 3 weeks (q3w), up to 8 cycles.~Used as a standard chemotherapy option in the control arm, with or without PD-1 inhibitor according to PD-L1 CPS score."

DRUG

PD-1 inhibitor

"A PD-1 inhibitor is administered intravenously at a fixed dose of 200 mg every 3 weeks.~It is combined with SOX in the experimental arm (CPS ≥1 patients) during conversion and adjuvant phases, and with CAPEOX or SOX in the control arm (CPS ≥1 patients).~Maintenance PD-1 inhibitor continues for up to 1 year or until disease progression or unacceptable toxicity."

RADIATION

Para-aortic lymph node radiotherapy (IMRT to station 16)

"Intensity-modulated radiotherapy (IMRT) is delivered postoperatively to the para-aortic (station 16) nodal basin.~Elective nodal basin: 45-50 Gy in 25 fractions Positive nodes: 56-60 Gy in 25 fractions Radiotherapy is given concurrently with oral capecitabine or S-1 as radiosensitizers."

DRUG

Capecitabine / S-1 (radiosensitizer during IMRT)

"During para-aortic IMRT, patients receive concurrent oral capecitabine 825 mg/m² twice daily on radiation days, or oral S-1 dosed according to body surface area.~These agents are used as radiosensitizers during postoperative radiotherapy."

All Listed Sponsors
lead

Jinbo Yue

OTHER