Apatinib Combined With Capecitabine Compared With Apatinib Treat Advanced Hepatocellular Carcinoma

NCT03114085 | Unknown Phase 2 DMC

• 1 other identifier: HRGX-001
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• time to progression

  From the randomization to the time of tumor progression

  through study completion, an average of 2 years

Study Arms (2)

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.

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;

Drug: Apatinib

Interventions

Capecitabine DRUG

Capecitabine 1000mg/m2 po bid, d1-d14, every 21 days for a cycle;

Also known as: Aibin

Apatinib Combined with Capecitabine

Apatinib DRUG

Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle

Also known as: Aitan

Apatinib; Apatinib Combined with Capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Capecitabine; apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Zhiming Zeng, Master

  Guangxi Medical University First Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiming Zeng, Master

CONTACT

8618677081832; zengzhiming031317@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 14, 2017
• Study Start: May 20, 2017
• Primary Completion: March 20, 2019
• Study Completion: May 20, 2019
• Last Updated: May 15, 2017

Record last verified: 2017-05