Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
nab-paclitaxel: Nab-paclitaxel is administered as an intravenous (IV) infusion at a dose of 125 mg/m² on day 1 of each 3-week cycle, for a total of 3 cycles in the neoadjuvant (preoperative) setting.
oxaliplatin: Oxaliplatin is administered as an intravenous (IV) infusion at a dose of 85 mg/m² on day 1 of each 3-week cycle, for a total of 3 cycles in the neoadjuvant (preoperative) setting.
S-1: S-1 is administered orally twice daily (BID) on days 2 to 15 of each 3-week cycle, for a total of 3 cycles. The dose is based on body surface area (BSA) as follows: BSA \< 1.25 m²: 40 mg BID (total 80 mg/day); BSA 1.25-1.5 m²: 50 mg BID (total 100 mg/day); BSA \> 1.5 m²: 60 mg BID (total 120 mg/day)
sintilimab: Sintilimab is administered as an intravenous (IV) infusion at a fixed dose of 200 mg on day 1 of each 3-week cycle, for a total of 3 cycles in the neoadjuvant (preoperative) setting.
D2 Gastrectomy: Curative-intent D2 radical gastrectomy is performed 3 to 6 weeks after completion of neoadjuvant therapy. The procedure includes either proximal, distal or total gastrectomy depending on tumor location, with en bloc resection of the stomach and systematic D2 lymphadenectomy according to Japanese Gastric Cancer Association (JGCA) guidelines. D2 lymph node dissection involves removal of both perigastric (N1) and second-tier (N2) lymph nodes.
Study summary
This study aims to evaluate the effectiveness and safety of a preoperative treatment (called neoadjuvant therapy) combining four drugs-nab-paclitaxel, oxaliplatin, S-1, and sintilimab-for patients with locally advanced, resectable early-onset gastric cancer (diagnosed at age 45 or younger).
All participants will receive this drug combination before undergoing surgery to remove the tumor. The goal is to shrink the tumor, increase the chance of complete surgical removal, and improve long-term outcomes.
This is a single-arm, open-label, phase II clinical trial, meaning all participants will receive the same treatment, and both doctors and patients will know what drugs are being used. The study is being conducted at Peking University People's Hospital.
Eligibility
Primary outcome measure(s)
- Pathological complete response (pCR) rate after neoadjuvant therapy — At the time of surgery, approximately 13-16 weeks from the start of neoadjuvant therapy
Pathological complete response (pCR) is defined as the absence of residual invasive tumor cells in the resected stomach and lymph nodes (ypT0N0), as assessed by centralized pathological review following D2 radical gastrectomy.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07018063 on ClinicalTrials.gov ↗ ← All trials in China