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Gastric (Cardia, Body) CancerPhase 2YOUNG-NEOSNCT07018063

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

A Phase 2 study testing nab-paclitaxel, oxaliplatin and S-1 in people with Gastric (Cardia, Body) Cancer and Stomach Adenocarcinoma, run by zhoujing at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 16 to 45 years
What is being tested?
nab-paclitaxel, oxaliplatin and S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
1 Oct 2025to 1 Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • Participants meeting any of the following criteria will be excluded:
  • 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;
  • History of other malignancies within the past 5 years;
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  • Active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis;
  • Active inflammatory bowel diseases, such as Crohn's disease or ulcerative colitis;
  • Currently receiving systemic corticosteroids or other immunosuppressive therapy;
  • Prior organ transplantation or use of anti-rejection medications;
  • Active tuberculosis, HIV infection, or severe active hepatitis B or C;
  • History of uncontrolled epilepsy, central nervous system disorders, or psychiatric illnesses that, in the investigator's judgment, may interfere with informed consent or compliance with oral medication;
  • Clinically significant (active) cardiac diseases, including symptomatic coronary artery disease, NYHA class II or above congestive heart failure , severe arrhythmias requiring medical intervention, or myocardial infarction within the past 12 months;
  • Presence of upper gastrointestinal obstruction that may impair the oral intake or absorption of S-1;
  • Severe uncontrolled recurrent infections or other uncontrolled serious comorbidities;
  • Use of any investigational drugs within 4 weeks prior to study enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

XUESONG ZHAO, M.D. contact

86+01088326600

xuesongzhao@bjmu.edu.cn

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    XUESONG ZHAO, M.D., 86+01088326600, xuesongzhao@bjmu.edu.cn

    YUSHI ZHOU, M.D.

Other trials in China

About this study

Official title: Efficacy and Safety of Neoadjuvant Nab-Paclitaxel Combined With Oxaliplatin, S-1, and Sintilimab in Patients With Locally Advanced Resectable Early-onset Gastric Cancer: A Phase II, Single-Arm, Open-Label Clinical 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.

Being tested
nab-paclitaxel, oxaliplatin, S-1, sintilimab, D2 Gastrectomy
Keywords
gastric cancer, Neoadjuvant therapy, Early-onset gastric cancer, Immunotherapy, Chemotherapy, Single-arm trial, Phase II trial, Perioperative treatment, China
Medical subject headings
Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nab-paclitaxelDrug

    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.

  • oxaliplatinDrug

    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-1Drug

    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)

  • sintilimabDrug

    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 GastrectomyProcedure or 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.

Study groups in NCT07018063
Study groupRoleWhat they receive
Neoadjuvant nab-SOX plus SintilimabExperimentalPatients will receive three 3-week cycles of neoadjuvant chemotherapy consisting of nab-paclitaxel 125 mg/m² IV on day 1, oxaliplatin 85 mg/m² IV on day 1, and S-1 80-120 mg/day orally on days 2-15, plus sintilimab 200 mg IV on day 1. D2 gastrectomy will be performed 3-6 weeks after neoadjuvant therapy.
Receives: Drug: nab-paclitaxel; Drug: oxaliplatin; Drug: S-1; Drug: sintilimab; Procedure: D2 Gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At the time of surgery, approximately 13-16 weeks from the start of neoadjuvant therapy

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 36 months after surgery

  5. Incidence of treatment-related grade 3 or higher adverse events

    Frequency and types of grade 3 or higher adverse events as defined by NCI CTCAE v5.0, recorded during neoadjuvant therapy to evaluate treatment safety.

    Measured: From initiation of treatment to surgery, approximately 12-15 weeks

  6. Incidence of major postoperative complications

    Postoperative complications will be recorded and classified using the Clavien-Dindo classification system, including but not limited to anastomotic leakage, surgical site infection, and postoperative bleeding.

    Measured: From surgery until hospital discharge or 30 days postoperatively, whichever is longer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All enrolled participants will receive the investigational treatment. No control group is included.
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07018063
Sponsor's protocol ID
PKUPH-EOGC-001
Acronym
YOUNG-NEOS
Status last verified
Jun 2025
First submitted
4 Jun 2025
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal.

Publications

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

  • Becker K, Mueller JD, Schulmacher C, Ott K, Fink U, Busch R, Bottcher K, Siewert JR, Hofler H. Histomorphology and grading of regression in gastric carcinoma treated with neoadjuvant chemotherapy. Cancer. 2003 Oct 1;98(7):1521-30. doi: 10.1002/cncr.11660.

    PubMed 14508841

  • Watson S, de la Fouchardiere C, Kim S, Cohen R, Bachet JB, Tournigand C, Ferraz JM, Lefevre M, Colin D, Svrcek M, Meurisse A, Louvet C. Oxaliplatin, 5-Fluorouracil and Nab-paclitaxel as perioperative regimen in patients with resectable gastric adenocarcinoma: A GERCOR phase II study (FOXAGAST). Eur J Cancer. 2019 Jan;107:46-52. doi: 10.1016/j.ejca.2018.11.006. Epub 2018 Dec 7.

    PubMed 30529902

  • Shitara K, Takashima A, Fujitani K, Koeda K, Hara H, Nakayama N, Hironaka S, Nishikawa K, Makari Y, Amagai K, Ueda S, Yoshida K, Shimodaira H, Nishina T, Tsuda M, Kurokawa Y, Tamura T, Sasaki Y, Morita S, Koizumi W. Nab-paclitaxel versus solvent-based paclitaxel in patients with previously treated advanced gastric cancer (ABSOLUTE): an open-label, randomised, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):277-287. doi: 10.1016/S2468-1253(16)30219-9. Epub 2017 Jan 19.

    PubMed 28404157

  • Zhang C, Tang R, Zhu H, Ge X, Wang Y, Wang X, Miao L. Comparison of treatment strategies and survival of early-onset gastric cancer: a population-based study. Sci Rep. 2022 Apr 15;12(1):6288. doi: 10.1038/s41598-022-10156-5.

    PubMed 35428811

  • Liu L, Lin J, Zhao J, Yan P. Analysis of clinicopathologic characteristics and prognosis of gastric cancer in patients <40 years. Medicine (Baltimore). 2023 Aug 25;102(34):e34635. doi: 10.1097/MD.0000000000034635.

    PubMed 37653814

  • Liu JD, Ye BT, Fu M, Zhang Q, Chen H, Sun J, Cai TY, Wang ZM, He HY, Zhao JJ, Li HJ, Wang XF, Sun YH. [Clinicopathological and molecular diagnostic features of early-onset gastric cancer: a study based on data from a single-center dedicated gastric cancer database]. Zhonghua Wei Chang Wai Ke Za Zhi. 2023 Oct 25;26(10):963-967. doi: 10.3760/cma.j.cn441530-20230603-00190. Chinese.

    PubMed 37849267

  • Pocurull A, Herrera-Pariente C, Carballal S, Llach J, Sanchez A, Carot L, Botargues JM, Cuatrecasas M, Ocana T, Balaguer F, Bujanda L, Moreira L. Clinical, Molecular and Genetic Characteristics of Early Onset Gastric Cancer: Analysis of a Large Multicenter Study. Cancers (Basel). 2021 Jun 23;13(13):3132. doi: 10.3390/cancers13133132.

    PubMed 34201547

  • Rompen IF, Nienhuser H, Crnovrsanin N, Musa J, Haag GM, Longerich T, Fiedler T, Muller-Stich BP, Sisic L, Billeter AT. Clinical Characteristics and Oncological Outcomes of Surgically Treated Early-Onset Gastric Adenocarcinoma - a Retrospective Cohort Study. J Cancer. 2023 May 21;14(9):1470-1478. doi: 10.7150/jca.82876. eCollection 2023.

    PubMed 37325055

  • Qu X, Zhao X, Liu Y, Wang N, Zhang L, Zhu X, Dong Q, Liu J, Shi Y. The clinicopathological characteristics of early-onset gastric cancer and its evolutionary trends: a retrospective study. Am J Cancer Res. 2022 Jun 15;12(6):2757-2769. eCollection 2022.

    PubMed 35812046

  • Ning FL, Zhang NN, Zhao ZM, Du WY, Zeng YJ, Abe M, Pei JP, Zhang CD. Global, Regional, and National Burdens with Temporal Trends of Early-, Intermediate-, and Later-Onset Gastric Cancer from 1990 to 2019 and Predictions up to 2035. Cancers (Basel). 2022 Nov 3;14(21):5417. doi: 10.3390/cancers14215417.

    PubMed 36358835

  • Lumish MA, Walch H, Maron SB, Chatila W, Kemel Y, Maio A, Ku GY, Ilson DH, Won E, Li J, Joshi SS, Gu P, Schattner MA, Laszkowska M, Gerdes H, Jones DR, Sihag S, Coit DG, Tang LH, Strong VE, Molena D, Stadler ZK, Schultz N, Janjigian YY, Cercek A. Clinical and molecular characteristics of early-onset vs average-onset esophagogastric cancer. J Natl Cancer Inst. 2024 Feb 8;116(2):299-308. doi: 10.1093/jnci/djad186.

    PubMed 37699004

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nab-paclitaxel, oxaliplatin and S-1 in people with Gastric (Cardia, Body) Cancer and Stomach Adenocarcinoma, run by zhoujing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact XUESONG ZHAO, M.D. (86+01088326600, xuesongzhao@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate after neoadjuvant therapy (time frame: At the time of surgery, approximately 13-16 weeks from the start of neoadjuvant therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07018063, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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