NCT04744649 (NICE) is a Phase 2 clinical trial of XELOX or SOX in Gastric Cancer, sponsored by Nanfang Hospital, Southern Medical University.

Who is sponsoring NCT04744649?

NCT04744649 is sponsored by Nanfang Hospital, Southern Medical University.

What drugs are being tested in NCT04744649?

Interventions in NCT04744649: XELOX or SOX, JS001+XELOX or SOX.

What condition does NCT04744649 study?

NCT04744649 studies Gastric Cancer, Stomach Neoplasm.

Is NCT04744649 still recruiting?

NCT04744649 is currently status unknown. Last updated 15 November 2022.

Last reviewed 2022-11-15 · How we verify

NCT04744649: NICE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neoadjuvant Immunotherapy and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial

Status unknown Phase 2 Last updated 15 November 2022

What this trial tests

Phase 2 trial testing XELOX or SOX in Gastric Cancer in 110 participants. Status unknown.

Timeline

12 March 2021

Primary endpoint
30 December 2023

30 December 2024

Quick facts

Lead sponsor	Nanfang Hospital, Southern Medical University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	110
Start date	12 March 2021
Primary completion	30 December 2023
Estimated completion	30 December 2024
Sites	10 locations across China

Drugs / interventions tested

XELOX or SOX — full drug profile →
JS001+XELOX or SOX — full drug profile →

Conditions studied

Gastric Cancer — all drugs for Gastric Cancer →
Stomach Neoplasm — all drugs for Stomach Neoplasm →

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 18 to 75, any sex, with Gastric Cancer or Stomach Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For locally advanced esophagogastric junction and gastric cancer (cT3-4aNxM0 or cT2N+M0), neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early before local therapy has begun, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate. JS001 in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate safety and efficacy of JS001 in combination with perioperative chemotherapy in locally advanced esophagogastric junction and gastric cancer. Differences in gut microbiome and tumor immune microenvironment were detected to screen people who were more sensitive to immunotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Harnessing the immune system against cancer: current immunotherapy approaches and therapeutic targets.
Kumar AR, Devan AR, Nair B, Vinod BS, et al · · 2021 · cited 98× · PMID 34671902 · DOI 10.1007/s11033-021-06752-9
Role of gut microbiome in cancer immunotherapy: from predictive biomarker to therapeutic target.
Zhang M, Liu J, Xia Q. · · 2023 · cited 77× · PMID 37770953 · DOI 10.1186/s40164-023-00442-x
PD-1 blockade synergizes with oxaliplatin-based, but not cisplatin-based, chemotherapy of gastric cancer.
Liu P, Chen J, Zhao L, Hollebecque A, et al · · 2022 · cited 50× · PMID 35769948 · DOI 10.1080/2162402x.2022.2093518
Gut Microbiota Modulation in the Context of Immune-Related Aspects of <i>Lactobacillus</i> spp. and <i>Bifidobacterium</i> spp. in Gastrointestinal Cancers.
Kaźmierczak-Siedlecka K, Roviello G, Catalano M, Polom K. · · 2021 · cited 49× · PMID 34444834 · DOI 10.3390/nu13082674
Potent therapeutic strategy in gastric cancer with microsatellite instability-high and/or deficient mismatch repair.
Ooki A, Osumi H, Yoshino K, Yamaguchi K. · · 2024 · cited 37× · PMID 38922524 · DOI 10.1007/s10120-024-01523-4
Heterogeneity and Adjuvant Therapeutic Approaches in MSI-H/dMMR Resectable Gastric Cancer: Emerging Trends in Immunotherapy.
Wu H, Ma W, Jiang C, Li N, et al · · 2023 · cited 23× · PMID 37667098 · DOI 10.1245/s10434-023-14103-0
Unlocking the Potential: Epstein-Barr Virus (EBV) in Gastric Cancer and Future Treatment Prospects, a Literature Review.
Corallo S, Lasagna A, Filippi B, Alaimo D, et al · · 2024 · cited 10× · PMID 39338919 · DOI 10.3390/pathogens13090728
Immunotherapy during the Immediate Perioperative Period: A Promising Approach against Metastatic Disease.
Sandbank E, Eckerling A, Margalit A, Sorski L, et al · · 2023 · cited 10× · PMID 37623021 · DOI 10.3390/curroncol30080540

Verify or expand the search:

Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting

Other Nanfang Hospital, Southern Medical University trials

Trials by the same sponsor.

NCT07091994 — A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy · Phase 4 · not yet recruiting
NCT06444022 — hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation · Phase 1 · withdrawn
NCT07537777 — Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted T · Phase 2 · not yet recruiting
NCT07481032 — Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients · NA · not yet recruiting
NCT07511894 — Beta-Blockers on the Efficacy of Neoadjuvant Immunotherapy for Gastric Cancer · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04744649 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nanfang Hospital, Southern Medical University
Last refreshed: 15 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04744649.

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