Hepatocellular CarcinomaPhase 2NCT03114085
Apatinib Combined With Capecitabine Compared With Apatinib Treat Advanced Hepatocellular Carcinoma
A Phase 2 study testing Capecitabine and Apatinib in people with Hepatocellular Carcinoma, run by First Affiliated Hospital of Guangxi Medical University.
Trial summary
It is an open,randomized,controlled study, and the purpose of this study is to observe and evaluate the efficacy and safety of Apatinib combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Capecitabine and Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2017to 20 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
.Inclusion Criteria:
- Age: ≥18-75 years old
- Recurrent / Metastatic non-resectable HCC patients who are in strict compliance with clinical diagnostic criteria of the Standard of Primary Liver Cancer Diagnosis and Treatment (2011 edition) or diagnosis by histopathology or cytology, and are unable to accept palliative surgery or radiotherapy, and have at least one measurable lesion (according to mRECIST, the measurable lesions spiral CT scan length ≥ 10mm or enlarged lymph node diameter ≥ 15mm); the largest tumor ≤ 10cm
- Child-Pugh liver function rating: A or better B (≤ 7 points)
- BCLC stage is B-C period
- ECOG PS score within 1 week before enrollment: 0-1 points
- Expected survival time ≥12 weeks
- The main organs function is normal, that is, meeting the following criteria:
Blood examination:
HB ≥ 90 g / L; ANC ≥ 1.5 × 109 / L; PLT ≥ 60 × 109 / L;
Biochemical examination:
ALB ≥ 29 g / L; ALT and AST < 2.5 ULN; TBIL ≤ 2ULN; Creatinine ≤ 1.5ULN; (Albumin and bilirubin two indicators can only have one for 2 points in Child-Pugh rating)
- Women of childbearing age shall undergo pregnancy tests within 7 days before enrollment
- People to be tested are volunteered to join the study and sign informed consent. They should have good compliance and are easy to follow-up .Exclusion Criteria:
- Patients with hepatic cholangiocarcinoma or mixed cell carcinoma or fibrous lamellar cell carcinoma; or at the same time with other untreated malignant tumors in the past (within 5 years), except for cured skin basal cell carcinoma and cervical carcinoma in situ
- Patients who are preparing for liver transplantation (except those who have undergone liver transplantation)
- Patients with high blood pressure, and it can't be reduced to normal range (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) by antihypertensive drug therapy
- Patients with level two or above myocardial ischemia or myocardial infarction, or poor controlled arrhythmia (including QTc interval men ≥ 450 ms, female ≥ 470 ms)
- According to NYHA standard Ⅲ ~ Ⅳ grade cardiac insufficiency or cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) <50%
- Have a variety of factors affecting oral drugs (such as can not swallow, chronic diarrhea and intestinal obstruction, significantly affect drug taking and absorption)
- There is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding in the past 6 months, such as: esophageal varicose veins with bleeding risk, local active ulcer lesions. Fecal occult blood ≥ (++) can not be grouped, if fecal occult blood (+),endoscopy is required
- Abdominal fistula, gastrointestinal perforation or abdominal abscess appeared within 28 days of participating in the study
- Coagulation dysfunction (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy
- Patients with central nervous system metastasis or brain metastases
- Patients who is suffering or had suffered pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function
- Urine test indicated urine protein ≥ ++ or confirmed 24 hours urine protein> 1.0 g
- A strong CYP3A4 inhibitor treatment was received within 7 days before the study, or a strong CYP3A4 inducer was received within 12 days before the study
- Pregnant or lactating women; fertility patients who are reluctant or unable to take effective contraceptive measures
- Patients with mental illness, or history of mental drug abuse
- Patients with bone metastases had received palliative radiotherapy (radiotherapy area> 5% bone marrow area) within 4 weeks before participating in the study
- Patients who are joint with HIV infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Apatinib Combined With Capecitabine Compared With Apatinib in the Treatment of Advanced Non-resectable Hepatocellular Carcinoma
It is an open,randomized,controlled study, and the purpose of this study is to observe and evaluate the efficacy and safety of Apatinib combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma.
Read the detailed description
This study is the clinical study of Apatinib combined with Capecitabine compared with Apatinib in the treatment of advanced non-resectable Hepatocellular Carcinoma, the object is patients with advanced hepatocellular carcinoma,its purpose is to observe and evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma, its main primary endpoint is TTP (time to progression) while the secondary endpoint is OS (overall survival), ORR (objective response rate), DCR (disease control rate), serum alpha-fetoprotein (AFP) levels and quality of life. 170 patients will be enrolled and 1:1 randomized into two groups: Apatinib combined Capecitabine and Apatinib alone. Major safety indicators are Vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE), drug-related AE and SAE, and specific AE (such as hypertension, proteinuria, and hand-foot syndrome), according to NCI-CTCAE.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Capecitabine, Apatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Aibin
Capecitabine 1000mg/m2 po bid, d1-d14, every 21 days for a cycle;
ApatinibDrug
Also called Aitan
Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle
| Study group | Role | What they receive |
|---|---|---|
| Apatinib Combined with Capecitabine | Experimental | Apatinib,500mg,once a day, orally (after breakfast),from day 1 to day 21 (including day 21) for continuous administration, every 21 days for one cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group; Capecitabine,1000mg/m2,twice a day (at intervals of 12 hours,equivalent to a total daily dose of 2000 mg / m2),orally,sustained 14 days, off for 7 days, every 21 days for a cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group. Receives: Drug: Capecitabine; Drug: Apatinib |
| Apatinib | Active comparator | Apatinib,500mg,once a day, orally (after breakfast),from day 1 to day 21 (including day 21) for continuous administration, every 21 days for one cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group; Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to progression
From the randomization to the time of tumor progression
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start20 May 2017 (estimated)
- Primary completion20 Mar 2019 (estimated)
- Study completion20 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeng Zhiming, First Affiliated Hospital of Guangxi Medical University
- Investigators
- Zhiming Zeng, Master, Principal investigator, Guangxi Medical University First Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114085
- Sponsor's protocol ID
- HRGX-001
- Status last verified
- May 2017
- First submitted
- 31 Mar 2017
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Combined With Capecitabine Compared With Apatinib in the Treatment of Advanced Non-resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03114085
- Acronym / sponsor ID
- HRGX-001
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (estimated)
- Primary completion
- 20 Mar 2019 (estimated)
- Study completion
- 20 May 2019 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is an open,randomized,controlled study, and the purpose of this study is to observe and evaluate the efficacy and safety of Apatinib combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma.
Detailed description
This study is the clinical study of Apatinib combined with Capecitabine compared with Apatinib in the treatment of advanced non-resectable Hepatocellular Carcinoma, the object is patients with advanced hepatocellular carcinoma,its purpose is to observe and evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma, its main primary endpoint is TTP (time to progression) while the secondary endpoint is OS (overall survival), ORR (objective response rate), DCR (disease control rate), serum alpha-fetoprotein (AFP) levels and quality of life. 170 patients will be enrolled and 1:1 randomized into two groups: Apatinib combined Capecitabine and Apatinib alone. Major safety indicators are Vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE), drug-related AE and SAE, and specific AE (such as hypertension, proteinuria, and hand-foot syndrome), according to NCI-CTCAE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib Combined with Capecitabine | Experimental | Drug: Capecitabine, Drug: ApatinibApatinib,500mg,once a day, orally (after breakfast),from day 1 to day 21 (including day 21) for continuous administration, every 21 days for one cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group; Capecitabine,1000mg/m2,twice a day (at intervals of 12 hours,equivalent to a total daily dose of 2000 mg / m2),orally,sustained 14 days, off for 7 days, every 21 days for a cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group. |
| Apatinib | Active comparator | Drug: ApatinibApatinib,500mg,once a day, orally (after breakfast),from day 1 to day 21 (including day 21) for continuous administration, every 21 days for one cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CapecitabineAlso: AibinCapecitabine 1000mg/m2 po bid, d1-d14, every 21 days for a cycle; | Drug | Apatinib Combined with Capecitabine |
| ApatinibAlso: AitanApatinib 500 mg po qd, d1-d21, every 21 days for one cycle | Drug | Apatinib, Apatinib Combined with Capecitabine |
Primary outcome
time to progression
Time frame: through study completion, an average of 2 years
From the randomization to the time of tumor progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Zhiming Zeng, Master principal investigator
Guangxi Medical University First Affiliated Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and Apatinib in people with Hepatocellular Carcinoma, run by First Affiliated Hospital of Guangxi Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiming Zeng, Master (8618677081832, zengzhiming031317@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to progression (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.