Carcinoma, HepatocellularPhase 3NCT02329860
Study of Apatinib After Systemic Therapy in Patients With Hepatocellular Carcinoma(AHELP)
A Phase 3 study testing Apatinib in people with Carcinoma, Hepatocellular, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2014to 14 Aug 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old.
- Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC (hepatocellular carcinoma) who cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation,and with at least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1.
- Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy (Failure is defined as documented radiological progression according to the radiology charter. Intolerance is defined as ≥ grade 4 hematologic toxicities, ≥ grade 3 non-hematologic toxicities ≥ grade 2 heart, liver or kidney damage).
- Systemic therapy must have been completed ≥2 weeks before randomization (AEs due to prior treatment ≤ grade 1).
- Liver function status Child-Pugh Class A or B (score≤7).
- Barcelona Clinic Liver Cancer stage Category B or C.
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- Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
- Life expectancy of at least 12 weeks.
- HBV DNA ≤ 2000IU/ml or 1×10E+4 copy/ml.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization.
- HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥80×10E+9/L; ALB ≥ 29g/L; ALT and AST < 5×ULN; TBIL ≤1.5×ULN; Cr ≤1.5×ULN
- Women of childbearing potential and men must agree to use adequate contraception .
Who cannot join
- Any local treatment (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks of randomization.
- Known hepatic duct carcinoma, mixed cell carcinoma or fibrolamellar hepatocellular carcinoma, known history or suffering from other cancer(except of cured skin basal cell carcinoma or carcinoma in situ of cervix).
- Patients who will receive liver transplantation.
- Ascites with clinical symptoms, i.e. require Abdominal paracentesis or drainage treatment such as or Child-Pugh Score>2.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
- Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms).
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- Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
- Factors to affect oral administration（such as Patients unable to swallow oral medications, chronic diarrhea and ileus etc. situations evidently affect drug oral medication and absorption）.
- Previous digestive tract bleeding history within 6 months or evident gastrointestinal bleeding tendency, such as,：Esophageal varices with bleeding risk, local active ulcerative lesions, fecal occult blood≥（++）；if fecal occult blood（+），gastroscope check is required.
- The Within 28 days ahead of randomization, experience abdomen fistula, gastrointestinal perforation, or abdominal abscess
- Coagulation abnormalities (INR > 1.5 x ULN, or PT > ULN +4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
- Occurrence of central nervous system metastatic or known brain metastatic;
- Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.
- Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g.
- Received powerful inhibitor of CYP3A4 within 7 days or powerful inducer of CYP3A4 within 12 days before randomization.
- Pregnant or breast-feeding women; patients with fertility will not or there is no way to adopt effective contraceptive measures.
- Mental disorders history, or Psychotropic drug abuse history.
- Patients who has bone metastasis, has received Palliative radiotherapy (radiotherapy area > 5% marrow area).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study (AHELP) of Apatinib in Patients With Hepatocellular Carcinoma After Systemic Therapy（Chemotherapy and/or Targeted Therapy）
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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Apatinib, Placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | 750 mg orally (p.o.) every day (qd), 28 days as one cycle Receives: Drug: Apatinib |
| Placebo | Placebo comparator | orally (p.o.) every day (qd), 28 days as one cycle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Approximately 36 months
Secondary outcomes (4)
Time to Progression（TTP）
Measured: Approximately 36 months
Progression Free Survival (PFS)
Measured: Approximately 36 months
Objective Response Rate
Measured: Approximately 36 months
Disease Control Rate
Measured: Approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study start26 Mar 2014
- Primary completion15 Dec 2017
- Study completion14 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NanJing PLA 81 Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329860
- Sponsor's protocol ID
- APTN-III-HCC
- Status last verified
- Jul 2017
- First submitted
- 30 Dec 2014
- Last updated
- 22 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Qin S, Li Q, Gu S, Chen X, Lin L, Wang Z, Xu A, Chen X, Zhou C, Ren Z, Yang L, Xu L, Bai Y, Chen L, Li J, Pan H, Cao B, Fang W, Wu W, Wang G, Cheng Y, Yu Z, Zhu X, Jiang D, Lu Y, Wang H, Xu J, Bai L, Liu Y, Lin H, Wu C, Zhang Y, Yan P, Jin C, Zou J. Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Jul;6(7):559-568. doi: 10.1016/S2468-1253(21)00109-6. Epub 2021 May 8.
PubMed 33971141
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study (AHELP) of Apatinib in Patients With Hepatocellular Carcinoma After Systemic Therapy（Chemotherapy and/or Targeted Therapy）
- ClinicalTrials.gov ID
- NCT02329860
- Acronym / sponsor ID
- APTN-III-HCC
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- NanJing PLA 81 Hospital
- Study start
- 26 Mar 2014 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib | Experimental | Drug: Apatinib750 mg orally (p.o.) every day (qd), 28 days as one cycle |
| Placebo | Placebo comparator | Drug: Placeboorally (p.o.) every day (qd), 28 days as one cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 18 years old.
- Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC (hepatocellular carcinoma) who cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation,and with at least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1.
- Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy (Failure is defined as documented radiological progression according to the radiology charter. Intolerance is defined as ≥ grade 4 hematologic toxicities, ≥ grade 3 non-hematologic toxicities ≥ grade 2 heart, liver or kidney damage).
- Systemic therapy must have been completed ≥2 weeks before randomization (AEs due to prior treatment ≤ grade 1).
- Liver function status Child-Pugh Class A or B (score≤7).
Key exclusion criteria (18 listed)
- Any local treatment (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks of randomization.
- Known hepatic duct carcinoma, mixed cell carcinoma or fibrolamellar hepatocellular carcinoma, known history or suffering from other cancer(except of cured skin basal cell carcinoma or carcinoma in situ of cervix).
- Patients who will receive liver transplantation.
- Ascites with clinical symptoms, i.e. require Abdominal paracentesis or drainage treatment such as or Child-Pugh Score>2.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib | Drug | Apatinib |
| Placebo | Drug | Placebo |
Primary outcome
Overall Survival
Time frame: Approximately 36 months
4 secondary outcomes
Time to Progression（TTP）
Time frame: Approximately 36 months
Progression Free Survival (PFS)
Time frame: Approximately 36 months
Objective Response Rate
Time frame: Approximately 36 months
Disease Control Rate
Time frame: Approximately 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33971141Qin S, Li Q, Gu S, Chen X, Lin L, Wang Z, Xu A, Chen X, Zhou C, Ren Z, Yang L, Xu L, Bai Y, Chen L, Li J, Pan H, Cao B, Fang W, Wu W, Wang G, Cheng Y, Yu Z, Zhu X, Jiang D, Lu Y, Wang H, Xu J, Bai L, Liu Y, Lin H, Wu C, Zhang Y, Yan P, Jin C, Zou J. Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Jul;6(7):559-568. doi: 10.1016/S2468-1253(21)00109-6. Epub 2021 May 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apatinib in people with Carcinoma, Hepatocellular, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Approximately 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024; AzTrials last refreshed its copy on 26 Oct 2026.