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Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer

ConditionsGastric (Cardia, Body) CancerStomach AdenocarcinomaLocally Advanced
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • nab-paclitaxel

    Drug

    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

    Drug

    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

    Drug

    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

    Drug

    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

    Procedure/Surgery

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Neoadjuvant nab-SOX plus SintilimabExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rate after 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.

Time frame
At the time of surgery, approximately 13-16 weeks from the start of neoadjuvant therapy

Secondary outcomes

1

R0 resection rate after neoadjuvant therapy and surgery

The proportion of patients achieving R0 resection, defined as complete macroscopic and microscopic tumor removal with negative margins.

Time frame
At the time of surgery, approximately 13-16 weeks from the start of treatment
2

Major pathological response (MPR) rate based on Becker tumor regression grade

The proportion of patients with residual tumor cells ≤10% in the primary tumor bed, corresponding to Becker TRG 1a and 1b categories, assessed by pathological review.

Time frame
At the time of surgery, approximately 13-16 weeks from the start of treatment
3

3-year disease-free survival (DFS)

DFS is defined as the time from informed consent to the first occurrence of tumor recurrence, metastasis, or death from any cause.

Time frame
Up to 36 months after surgery
4

3-year overall survival (OS)

OS is defined as the time from informed consent to death from any cause. Censoring will occur at the last follow-up for event-free patients.

Time frame
Up to 36 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

zhoujing

Lead sponsor

Peking University People's Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: