Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastri… (NCT07018063) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer
China35 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range16 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must meet all of the following inclusion criteria:
* 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;
* For GEJ cancer: clinical stage cT2-T4a N+ M0;
* For cT4b Nany M0 cases: location may be gastric body or GEJ.
* Staging is based on contrast-enhanced CT, MRI (if needed), and endoscopic ultrasonography (EUS) (if needed);
* Assessed as resectable after multidisciplinary team (MDT) discussion;
* Surgical evaluation confirms that D2 radical gastrectomy is feasible;
* Sufficient physical condition and organ function to tolerate major abdominal surgery;
* Baseline laboratory tests meet the following criteria:
* Hemoglobin ≥90 g/L
* Absolute neutrophil count (ANC) ≥1.5×10⁹/L
* Platelets ≥100×10⁹/L
* ALT and AST ≤2.5× upper limit of normal (ULN)
* Alkaline phosphatase (ALP) ≤2.5× ULN
* Total bilirubin \<1.5× ULN
* Serum creatinine \<1× ULN
* Serum albumin ≥30 g/L
* No severe comorbidities that may limit life expectancy to \<3 years;
* Participant is willing and able to comply with the study protocol during the study period;
* Written informed consent must be signed before screening. Participants must understand their right to withdraw at any time without any loss of benefits;
* Willing to provide blood and tissue samples.
Exclusion Criteria:…
What they're measuring
1
Pathological complete response (pCR) rate after neoadjuvant therapy
Timeframe: At the time of surgery, approximately 13-16 weeks from the start of neoadjuvant therapy