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NCT04806945
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
Phase 3 trial testing HLX10 in Cervical Cancer. Withdrawn.
15 February 2024
Quick facts
| Lead sponsor | Shanghai Henlius Biotech |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 30 September 2022 |
| Primary completion | 15 February 2024 |
| Estimated completion | 30 October 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- HLX10
- Paclitaxel — full drug profile →
- Cisplatin (cisplatin) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
- Placebo to HLX10 — full drug profile →
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
Sponsor
Shanghai Henlius Biotech — full company profile →
Who can join
Adults 18 to 75, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the efficacy and safety of HLX10(Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) plus chemotherapy compared to the efficacy and safety of placebo plus chemotherapy in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Chemotherapy regimens include: paclitaxel plus cisplatin and paclitaxel plus carboplatin. The primary study hypotheses are that the combination of HLX10 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the IRRC or, 2) Overall Survival (OS).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
PD-1/PD-L1 inhibitors for advanced or metastatic cervical cancer: From bench to bed.
Huang W, Liu J, Xu K, Chen H, et al · · 2022 · cited 30× · PMID 36313730 · DOI 10.3389/fonc.2022.849352 -
Immunotherapy in cervical cancer: From the view of scientometric analysis and clinical trials.
Xing Y, Yasinjan F, Du Y, Geng H, et al · · 2023 · cited 9× · PMID 36817443 · DOI 10.3389/fimmu.2023.1094437
Verify or expand the search:
- PubMed search for NCT04806945
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06349980 — A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or W · Phase 2 · recruiting
- NCT06115642 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors · Phase 1 · recruiting
Other recruiting trials for Cervical Cancer
Currently open trials in the same condition.
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- NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · 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 NCT04806945 (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: 5 May 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/NCT04806945.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing