- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03950518
Novel Treatment of Advanced Hepatocellular Carcinoma (NTAHCC)
Multicenter, Randomized, Open, Parallel, Prospective, Exploratory Clinical Study of Arginine Hydrochloride and Levamisole in the Treatment of Advanced HCC
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Recruiting
- The First Affiliated hospital of Zhengzhou University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Ages 18-65 years
2. The diagnosis of ICC: in accordance with "diagnostic and treating standards on primary liver cancer" or histological/cytological diagnosis of primary liver cancer
3. 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
4. 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);
5. Child-Pugh liver function class A/B(score: ≤7)
6. Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale in one week before admission
7. Estimated survival time > 3 months
8. HBV DNA#2000 IU/ml#10^4 copies/ml); or HBV DNA≥2000 IU/ml and are accepting effective antiviral therapy
9. 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
1.5ULN( albumin and bilirubin, two indicators of Child-Pugh liver function class, can only have one for 2 points)
10. 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
11. volunteers must signed informed consent
Exclusion Criteria:
1. 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 ≥#++#
2. 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
3. Patients who are undergoing liver transplantation or have a history of organ transplantation(excluding the patient who has undergone liver transplantation before)
4. Patients with an allergic history of Levamisole Hydrochloride and Anlotinib Hydrochloride Capsules
5. 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)
6. Patients with myocardial ischemia or myocardial infarction over grade II or a poorly controlled arrhythmia (including QTc interval: men ≥ 450 ms; women ≥ 470 ms)
7. Cardiac functional insufficiency of grade III to IV according to NYHA standard; echocardiography: LVEF#50%
8. 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
9. Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before participating the study
10. 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
11. 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
12. Urine routine showed that urine protein ≥++ or the urine protein in 24 hours#1.0 g
13. 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.
14. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives
15. Patients with mental sickness or the history of psychotropic drug abuse
16. Patients with severe infection (unable to control the infection effectively)
17. The treatment history affecting this program or its efficacy, such as stem cell transplantation, immune regulation (including PD-1 and other test regimens) recently (within half a year)
18. The researchers believe that any other factors unsuitable for entering into the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: One-drug Regimes
Drug: Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;
|
Anlotinib Hydrochloride Capsules, 12mg/d
Other Names:
|
EXPERIMENTAL: Two-drug Regimes
Anlotinib Hydrochloride Capsules Arginine hydrochloride
|
Anlotinib Hydrochloride Capsules, 12mg/d
Other Names:
AHC,12mg/d AH,40g/d
Other Names:
|
EXPERIMENTAL: Three-drug Regimes
Anlotinib Hydrochloride Capsules Arginine hydrochloride Levamisole Hydrochloride
|
Anlotinib Hydrochloride Capsules, 12mg/d
Other Names:
AHC,12mg/d AH,40g/d
Other Names:
AHC,12mg/d AH,40mg/d LM,150mg/d
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
Time Frame: 24 months
|
Time from start of treatment until the first documented event of symptomatic progression or death
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 48 months
|
Time from start of treatment to death from any cause, or last known date of survival
|
48 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate (DCR)
Time Frame: 28 days
|
the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
|
28 days
|
Objective Response Rate(ORR)
Time Frame: 28 days
|
Proportion of patients with reduction in tumor burden of a predefined amount
|
28 days
|
The change of AFP biomarker
Time Frame: approximately 24 months
|
Concentration of AFP biomarker change in tumor markers
|
approximately 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HETCT-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HCC
-
University of PisaAzienda Ospedaliera Città della Salute e della Scienza di Torino; Fondazione... and other collaboratorsRecruiting
-
Seoul National University HospitalPhilips HealthcareCompleted
-
Huazhong University of Science and TechnologyUnknown
-
Taipei Medical University WanFang HospitalTerminated
-
Leiden University Medical CenterMedtronic; ZonMw: The Netherlands Organisation for Health Research and Development and other collaboratorsCompletedHCC | Early Stage HCCNetherlands
-
Qianfoshan HospitalNot yet recruiting
-
Xuhua DuanRecruiting
-
Ain Shams UniversityCompleted
-
Shenyang Tenth People's HospitalBeijing Tsinghua Changgeng HospitalNot yet recruiting
Clinical Trials on Anlotinib Hydrochloride Capsules
-
Peking University Third HospitalNot yet recruitingNon-Small Cell Lung Cancer
-
Xianhai MaoChia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingHepatocellular Carcinoma | Adjuvant TherapyChina
-
Sun Yat-sen UniversityUnknownHead and Neck CancerChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingMGMT-Unmethylated GlioblastomaChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingDiffuse Large B-cell LymphomaChina
-
Xijing HospitalNot yet recruiting
-
Jinming YuRecruitingLimited Stage Small Cell Lung Cancer | Not Progressed After First-line ChemoradiotherapyChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruiting
-
Cancer Institute and Hospital, Chinese Academy...RecruitingPatients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or MetastasiChina