Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-45
Sponsorzhoujing
About this trial
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 criteria
Qualifiers
Male or female, aged ≥16 and ≤45 years;
Karnofsky performance score ≥70% or ECOG performance status 0-1;
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
For gastric body cancer: clinical stage cT3-T4a N+ M0;
Disqualifiers
Patients with HER-2 positive gastric cancer, as determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH);
Patients with dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high) tumors, as determined by IHC;
Pregnant or breastfeeding women;
Prior treatment for gastric cancer with cytotoxic chemotherapy, radiotherapy, or immunotherapy;
Trial design
Treatments tested in this trial
- nab-paclitaxel
- oxaliplatin
- S-1
- sintilimab
- D2 Gastrectomy
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
zhoujing
Lead sponsor
Peking University People's Hospital
Sponsor institution
Source ClinicalTrials.gov