Who is sponsoring NCT04486651?

NCT04486651 is sponsored by Taizhou Hanzhong biomedical co. LTD.

What drugs are being tested in NCT04486651?

Interventions in NCT04486651: Irinotecan Hydrochloride Injection, HX008, Placebo.

What condition does NCT04486651 study?

NCT04486651 studies Stomach Cancer.

Is NCT04486651 still recruiting?

NCT04486651 is currently status unknown. Last updated 28 January 2021.

Last reviewed 2021-01-28 · How we verify

NCT04486651

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

HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

Status unknown Phase 3 Last updated 28 January 2021

What this trial tests

Phase 3 trial testing Irinotecan Hydrochloride Injection in Stomach Cancer in 560 participants. Status unknown.

Timeline

16 September 2020

Primary endpoint
10 August 2023

10 August 2023

Quick facts

Lead sponsor	Taizhou Hanzhong biomedical co. LTD
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	560
Start date	16 September 2020
Primary completion	10 August 2023
Estimated completion	10 August 2023
Sites	64 locations across China

Drugs / interventions tested

Irinotecan Hydrochloride Injection
HX008 — full drug profile →
Placebo

Conditions studied

Stomach Cancer — all drugs for Stomach Cancer →

Sponsor

Taizhou Hanzhong biomedical co. LTD — full company profile →

Who can join

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

Sponsor's own description

This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine therapy.

Publications & conference data

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

Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z
Salvage systemic therapy for advanced gastric and oesophago-gastric junction adenocarcinoma.
Tomita Y, Moldovan M, Chang Lee R, Hsieh AH, et al · · 2020 · cited 14× · PMID 33210731 · DOI 10.1002/14651858.cd012078.pub2
A Clinical Viewpoint on the Use of Targeted Therapy in Advanced Gastric Cancer.
Skórzewska M, Gęca K, Polkowski WP. · · 2023 · cited 11× · PMID 38001751 · DOI 10.3390/cancers15225490
Phase I study of pucotenlimab (HX008), an anti-PD-1 antibody, for patients with advanced solid tumors.
Liu R, Li W, Meng Y, Gao S, et al · · 2021 · cited 8× · PMID 34158838 · DOI 10.1177/17588359211020528

Verify or expand the search:

Other trials of Irinotecan Hydrochloride Injection

Trials testing the same drug.

NCT04714190 — A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression · Phase 3 · unknown

Other recruiting trials for Stomach Cancer

Currently open trials in the same condition.

NCT07504367 — Large Language Models Assist in Tumor MDT · NA · recruiting
NCT07310888 — Robotic Gastrectomy With 5th Arm · NA · recruiting
NCT07070466 — Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA · Phase 2 · recruiting
NCT06028737 — Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer · Phase 2, PHASE3 · recruiting
NCT06263088 — EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastroint · NA · recruiting

Other Taizhou Hanzhong biomedical co. LTD trials

Trials by the same sponsor.

NCT05647954 — A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage · Phase 3 · unknown
NCT05652894 — A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal · Phase 3 · not yet recruiting
NCT04741165 — Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC · Phase 2 · unknown
NCT04574817 — Study of HX008 for the Treatment of Anaplastic Thyroid Cancer (ATC) · Phase 2 · unknown
NCT04750083 — HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or · Phase 2, PHASE3 · unknown

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 NCT04486651 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Taizhou Hanzhong biomedical co. LTD
Last refreshed: 28 January 2021

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/NCT04486651.

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