Novel Treatment of Advanced Hepatocellular Carcinoma

NCT03950518 | Unknown Phase 3

• 1 other identifier: HETCT-002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of arginine hydrochloride combined with Levamisole in the treatment of patients with hepatocellular carcinoma.

Conditions

HCC

Keywords

treatment

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Time from start of treatment until the first documented event of symptomatic progression or death

  24 months

Secondary Outcomes (1)

• Overall Survival

  48 months

Other Outcomes (3)

• Disease Control Rate (DCR)

  28 days

• Objective Response Rate(ORR)

  28 days

• The change of AFP biomarker

  approximately 24 months

Study Arms (3)

One-drug Regimes

EXPERIMENTAL

Drug: Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;

Drug: Anlotinib Hydrochloride Capsules

Two-drug Regimes

EXPERIMENTAL

Anlotinib Hydrochloride Capsules Arginine hydrochloride

Drug: Anlotinib Hydrochloride Capsules; Drug: Arginine hydrochloride

Three-drug Regimes

EXPERIMENTAL

Anlotinib Hydrochloride Capsules Arginine hydrochloride Levamisole Hydrochloride

Drug: Anlotinib Hydrochloride Capsules; Drug: Arginine hydrochloride; Drug: levamisole

Interventions

Anlotinib Hydrochloride Capsules DRUG

Anlotinib Hydrochloride Capsules, 12mg/d

Also known as: AHC

One-drug Regimes; Three-drug Regimes; Two-drug Regimes

Arginine hydrochloride DRUG

AHC,12mg/d AH,40g/d

Also known as: AH+AHC

Three-drug Regimes; Two-drug Regimes

levamisole DRUG

AHC,12mg/d AH,40mg/d LM,150mg/d

Also known as: AH+AHC+LM

Three-drug Regimes

Eligibility Criteria

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

You may qualify if:

• \. Ages 18-65 years
• \. The diagnosis of ICC: in accordance with "diagnostic and treating standards on primary liver cancer" or histological/cytological diagnosis of primary liver cancer
• \. Un-resectable HCC : patients with developing primary liver cancer of Barcelona stage(BCLC) B; multiple nodules (less than 5, the total diameter of less than 20 cm), no invasion, no symptoms;refusing open surgical treatment and volunteering for the treatment
• \. The First-line system therapy failure (or residual lesion) from the group of this study a signed informed consent (time) for 2 weeks or more basic returned to normal and adverse events (NCI CTCAE Ⅰ level or less);
• \. Child-Pugh liver function class A/B(score: ≤7)
• \. Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale in one week before admission
• \. Estimated survival time \> 3 months
• \. HBV DNA#2000 IU/ml#10\^4 copies/ml); or HBV DNA≥2000 IU/ml and are accepting effective antiviral therapy
• \. The major organ function is normal. that is meeting the following standards:
• Blood routine examination: (No blood transfusion, no G-CSF and no medication were corrected within 14 days before screening)
• HB≥80g/L# b.ANC≥1.5×109/L#c.PLT≥50×109/L#
• Biochemical examination: (ALB was not transfused within 14 days before screening) a.ALB ≥29 g/L# b.ALT#AST\<5ULN#c.TBIL ≤3ULN#d.creatinine
• ULN( albumin and bilirubin, two indicators of Child-Pugh liver function class, can only have one for 2 points)
• \. For women of childbearing age, the results of serum/urine pregnancy tests must be negative within 7 days before initiation of treatment. All men and women who participate in the study have to take reliable contraceptive measures within the trial and eight weeks after the trial is completed
• \. volunteers must signed informed consent

You may not qualify if:

• \. With a history of alimentary tract hemorrhage or a definite tendency of gastrointestinal bleeding, such as varices of fundus of stomach and esophagus with bleeding risk; local active ulcer lesions; fecal occult blood ≥#++#
• \. Patients with hepatobiliary cell carcinoma, mixed cell carcinoma or lamellar cell carcinoma; in the past (within 5 years) or at the same time suffering from other untreated malignant tumors; excluding cured basal cell carcinoma and carcinoma in situs of cervix
• \. Patients who are undergoing liver transplantation or have a history of organ transplantation(excluding the patient who has undergone liver transplantation before)
• \. Patients with an allergic history of Levamisole Hydrochloride and Anlotinib Hydrochloride Capsules
• \. The blood pressure can not be reduced to the normal range by the antihypertensive drug treatment in patients with hypertension(systolic pressure#140 mmHg, diastolic pressure#90 mmHg)
• \. Patients with myocardial ischemia or myocardial infarction over grade II or a poorly controlled arrhythmia (including QTc interval: men ≥ 450 ms; women ≥ 470 ms)
• \. Cardiac functional insufficiency of grade III to IV according to NYHA standard; echocardiography: LVEF#50%
• \. Many factors that influence oral medication, such as unable to swallow; chronic diarrhea; intestinal obstruction; the situations which significantly affect the use and absorption of drugs
• \. Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before participating the study
• \. Dysfunction of blood coagulation(INR#2.0 or PT# 16s#APTT \> 43s#TT \> 21s#Fbg \< 2g/L), having a tendency to bleed or undergoing thrombolysis or anticoagulant therapy; ascites with clinical symptoms, that is requiring therapeutic abdominal paracentesis or drainage or Child-Pugh score ≥2
• \. Objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment in the past and at present
• \. Urine routine showed that urine protein ≥++ or the urine protein in 24 hours#1.0 g
• \. Patients who have been treated with potent CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, telithromycin, troleandomycin, erythromycin, cimetidine and so on) within 28 days before participating the study, or potent CYP3A4 inducers (dexamethasone, phenytoin, rifampin, rifabutin, carbamazepine, phenobarbitone and so on) within 12 days before participating the study.
• \. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives
• \. Patients with mental sickness or the history of psychotropic drug abuse

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead
• Luoyang Central Hospital: collaborator
• Nanyang Central Hospital: collaborator
• Anyang Tumor Hospital: collaborator
• The Third People's Hospital of Jiaozuo: collaborator
• Sanmenxia Central Hospital: collaborator
• Pingdingshan Coal Medical Group General Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Interventions

Arginine; Levamisole

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of infectious diseases department

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 15, 2019
• Study Start: April 10, 2019
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: May 15, 2019

Record last verified: 2019-04

Locations

CN (1)