Last reviewed · How we verify
NCT03958890
A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Phase 3 trial testing HLX10 100 mg in 10 ml Injection in Esophageal Squamous Cell Carcinoma in 489 participants. Status unknown.
30 April 2023
Quick facts
| Lead sponsor | Shanghai Henlius Biotech |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 489 |
| Start date | 19 June 2019 |
| Primary completion | 30 April 2023 |
| Estimated completion | 30 December 2023 |
| Sites | 7 locations across China |
Drugs / interventions tested
- HLX10 100 mg in 10 ml Injection — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
Sponsor
Shanghai Henlius Biotech — full company profile →
Who can join
Adults 18 to 75, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a randomized, double-blind, multi-center, phase III clinical study comparing the clinical efficacy and safety of HLX10 or placebo combined with chemotherapy in first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531 -
Advances and challenges in the treatment of esophageal cancer.
He S, Xu J, Liu X, Zhen Y. · · 2021 · cited 223× · PMID 34900524 · DOI 10.1016/j.apsb.2021.03.008 -
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476 -
First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial.
Song Y, Zhang B, Xin D, Kou X, et al · · 2023 · cited 134× · PMID 36732627 · DOI 10.1038/s41591-022-02179-2 -
Immune checkpoint inhibitors: breakthroughs in cancer treatment.
Kong X, Zhang J, Chen S, Wang X, et al · · 2024 · cited 71× · PMID 38801082 · DOI 10.20892/j.issn.2095-3941.2024.0055 -
Recent developments in immunotherapy for gastrointestinal tract cancers.
Chong X, Madeti Y, Cai J, Li W, et al · · 2024 · cited 52× · PMID 39123202 · DOI 10.1186/s13045-024-01578-x -
The Combination Options and Predictive Biomarkers of PD-1/PD-L1 Inhibitors in Esophageal Cancer.
Yang H, Wang K, Wang T, Li M, et al · · 2020 · cited 35× · PMID 32195194 · DOI 10.3389/fonc.2020.00300 -
Current status and perspectives of esophageal cancer: a comprehensive review.
Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645
Verify or expand the search:
- PubMed search for NCT03958890
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Esophageal Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07385001 — A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as N · Phase 1, PHASE2 · recruiting
- NCT07217171 — A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial · Phase 1 · recruiting
- NCT07109726 — A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations · Phase 1, PHASE2 · recruiting
- NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting
Other Shanghai Henlius Biotech trials
Trials by the same sponsor.
- NCT07518043 — A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors · Phase 1 · not yet recruiting
- NCT07477587 — A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in · Phase 1 · not yet recruiting
- NCT07533708 — A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours · Phase 1 · not yet recruiting
- NCT07484893 — A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects · Phase 1 · not yet recruiting
- NCT07495930 — Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® · Phase 1 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT03958890 (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 Shanghai Henlius Biotech
- Last refreshed: 18 April 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/NCT03958890.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing