Who is sponsoring NCT06158919?

NCT06158919 is sponsored by Fudan University.

What drugs are being tested in NCT06158919?

Interventions in NCT06158919: Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine.

What condition does NCT06158919 study?

NCT06158919 studies Gastric Cancer/Adenocarcinoma of Esophagogastric Junction.

Is NCT06158919 still recruiting?

NCT06158919 is currently recruiting now. Last updated 6 December 2023.

Last reviewed 2023-12-06 · How we verify

NCT06158919: G/GEJ cancer

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

A Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer

Recruiting now NA Last updated 6 December 2023

What this trial tests

NA trial testing Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine in Gastric Cancer/Adenocarcinoma of Esophagogastric Junction in 58 participants. Currently enrolling.

Timeline

20 November 2023

Primary endpoint
20 November 2024

20 November 2026

Quick facts

Lead sponsor	Fudan University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	20 November 2023
Primary completion	20 November 2024
Estimated completion	20 November 2026
Sites	1 location across China

Drugs / interventions tested

Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine — full drug profile →

Conditions studied

Gastric Cancer/Adenocarcinoma of Esophagogastric Junction — all drugs for Gastric Cancer/Adenocarcinoma of Esophagogastric Junction →

Sponsor

Fudan University

Who can join

Adults 18 to 80, any sex, with Gastric Cancer/Adenocarcinoma of Esophagogastric Junction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, single-arm, single-center clinical study to investigate the safety and efficacy of fuquinitinib combined with PD-1 inhibitors and first-line chemotherapy in the treatment of inoperable HER2-negative advanced GC/GEJC. Eligible enrolled patients received 6 cycles of combined treatment with fuquinitinib combined with PD-1 inhibitor and chemotherapy (XELOX/SOX) regimen. Maintenance treatment was fuquinitinib combined with PD-1 inhibitor and Teghio/capecitabine until disease progression or toxicity became intolerable. The longest duration of PD-1 inhibitor treatment is 24 months.

Publications & conference data

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

Clinical advances and challenges of anti-angiogenic targeted therapy in gastric cancer.
Wu Z, Ni J, Xu Q. · · 2025 · PMID 41211418 · DOI 10.3389/fonc.2025.1654300
Fruquintinib and sintilimab plus SOX as perioperative therapy for locally resectable advanced gastric/gastroesophageal junction adenocarcinoma: study protocol for a prospective, single-arm, phase II clinical trial.
Meng X, Yang D, Liu Y, Wang C, et al · · 2025 · PMID 40799651 · DOI 10.3389/fimmu.2025.1638316

Verify or expand the search:

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile 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 NCT06158919 (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 Fudan University
Last refreshed: 6 December 2023

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/NCT06158919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing