Overall Survival
Primary
· Approximately 36 months
| Group | Value | 95% CI |
|---|---|---|
| Apatinib | 8.7 | 7.5 – 9.8 |
| Placebo | 6.8 | 5.7 – 9.1 |
Last reviewed · How we verify
NCT02329860
Study of Apatinib After Systemic Therapy in Patients With Hepatocellular Carcinoma(AHELP)
Completed
Phase 3
Results posted
Last updated 22 January 2024
What this trial tests
Phase 3 trial testing Apatinib in Carcinoma, Hepatocellular in 400 participants. Completed in 14 August 2019.
Timeline
26 March 2014
Primary endpoint
15 December 2017
15 December 2017
14 August 2019
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 26 March 2014 |
| Primary completion | 15 December 2017 |
| Estimated completion | 14 August 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Apatinib (Apatinib) — full drug profile →
- Placebo
Conditions studied
- Carcinoma, Hepatocellular — all drugs for Carcinoma, Hepatocellular →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Carcinoma, Hepatocellular. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Progression（TTP）
Secondary
· Approximately 36 months
| Group | Value | 95% CI |
|---|---|---|
| Apatinib | 4.7 | 4.5 – 4.8 |
| Placebo | 1.9 | 1.9 – 2.0 |
Progression Free Survival (PFS)
Secondary
· Approximately 36 months
| Group | Value | 95% CI |
|---|---|---|
| Apatinib | 4.5 | 3.9 – 4.7 |
| Placebo | 1.9 | 1.9 – 2.0 |
Objective Response Rate
Secondary
· Approximately 36 months
| Group | Value | 95% CI |
|---|---|---|
| Apatinib | 10.7 | 7.2 – 15.1 |
| Placebo | 1.5 | 0.2 – 5.4 |
Disease Control Rate
Secondary
· Approximately 36 months
| Group | Value | 95% CI |
|---|---|---|
| Apatinib | 61.3 | 55.1 – 67.2 |
| Placebo | 28.8 | 21.2 – 37.3 |
Adverse events — posted to ClinicalTrials.gov
Time frame: approximately 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Apatinib
Serious: 95/257 (37%)
Deaths: 24/257
Placebo
Serious: 30/130 (23%)
Deaths: 13/130
Serious adverse events (78 terms)
| Reaction | System | Apatinib | Placebo |
|---|---|---|---|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Death | General disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — |
| Overdose | Injury, poisoning and procedural complications | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Multiple organ dysfunction syndrome | General disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Cerebral haemorrhage | Nervous system disorders | — | — |
| Encephalopathy | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Hepatic failure | Hepatobiliary disorders | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
Other adverse events (56 terms — click to expand)
| Reaction | System | Apatinib | Placebo |
|---|---|---|---|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Hypertension | Vascular disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| White blood cell count decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Asthenia | General disorders | — | — |
| Bilirubin conjugated increased | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — |
| Protein urine present | Investigations | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Blood bilirubin unconjugated increased | Investigations | — | — |
| Blood pressure increased | Investigations | — | — |
| Dizziness | Nervous system disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Mouth ulceration | Gastrointestinal disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Blood urine present | Investigations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Upper gastrointestinal haemorrhage, Death, Lung infection, Hepatic encephalopathy, Overdose, Gastrointestinal haemorrhage, Hepatic function abnormal, Haemoptysis.
Data from ClinicalTrials.gov NCT02329860 adverse events section.
Sponsor's own description
This was a multicenter, randomized, double-blind, phase III trial. This clinical study evaluates the efficacy and safety of Apatinib in patients with advanced liver cancer who have progressed on Systemic Therapy (Chemotherapy and/or Targeted Therapy). Approximately 400 patients who meet the entry criteria will be randomly assigned in a 2:1 ratio to Apatinib or placebo (1/3 chance to receive placebo). Primary endpoint of the study is overall survival.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular therapies and precision medicine for hepatocellular carcinoma.
Llovet JM, Montal R, Sia D, Finn RS. · · 2018 · cited 1481× · PMID 30061739 · DOI 10.1038/s41571-018-0073-4 -
Targeted therapy for hepatocellular carcinoma.
Huang A, Yang XR, Chung WY, Dennison AR, et al · · 2020 · cited 548× · PMID 32782275 · DOI 10.1038/s41392-020-00264-x -
Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.
Qin S, Li Q, Gu S, Chen X, et al · · 2021 · cited 200× · PMID 33971141 · DOI 10.1016/s2468-1253(21)00109-6 -
Apatinib for molecular targeted therapy in tumor.
Zhang H. · · 2015 · cited 162× · PMID 26622168 · DOI 10.2147/dddt.s97235 -
Genomic Medicine and Implications for Hepatocellular Carcinoma Prevention and Therapy.
Dhanasekaran R, Nault JC, Roberts LR, Zucman-Rossi J. · · 2019 · cited 157× · PMID 30404026 · DOI 10.1053/j.gastro.2018.11.001 -
Recent advances in systemic therapy for hepatocellular carcinoma.
Zhang H, Zhang W, Jiang L, Chen Y. · · 2022 · cited 150× · PMID 35000616 · DOI 10.1186/s40364-021-00350-4 -
Chemotherapy for hepatocellular carcinoma: The present and the future.
Le Grazie M, Biagini MR, Tarocchi M, Polvani S, et al · · 2017 · cited 123× · PMID 28824742 · DOI 10.4254/wjh.v9.i21.907 -
Angiogenesis in hepatocellular carcinoma: mechanisms and anti-angiogenic therapies.
Yao C, Wu S, Kong J, Sun Y, et al · · 2023 · cited 111× · PMID 36647777 · DOI 10.20892/j.issn.2095-3941.2022.0449
Verify or expand the search:
- PubMed search for NCT02329860
- Europe PMC full search
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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 NCT02329860 (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 Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 22 January 2024
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/NCT02329860.
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