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HCCPhase 3NTAHCCNCT03950518

Novel Treatment of Advanced Hepatocellular Carcinoma

A Phase 3 study testing Anlotinib Hydrochloride Capsules, Arginine hydrochloride and levamisole in people with HCC, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HCC
What is being tested?
Anlotinib Hydrochloride Capsules, Arginine hydrochloride and levamisole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
10 Apr 2019to 10 Apr 2023
Phase
Phase 3
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Zujiang Yu, pro, 0086-0371-67966942, johnyuem@zzu.edu.cn

    Juan Li, pro, 0086-0371-67966942, ananli1984@126.com

    Recruiting

Other trials in China

About this study

Official title: Multicenter, Randomized, Open, Parallel, Prospective, Exploratory Clinical Study of Arginine Hydrochloride and Levamisole in the Treatment of Advanced HCC

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.

Read the detailed description

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause of cancer-related deaths in the world. Because HCC is insidious and early diagnosis is difficult, most patients have locally advanced or distant metastasis at the time of diagnosis. So they are not suitable candidates for curative treatments by resection or transplantation. Currently, There are only not more than five drugs to be selected for advanced HCC, although it prolongs the survival for less than 3 months. Recently, metabolomics studies of HCC have shown that typical Warburg effect was observed in hepatoma carcinoma cells. Arginine hydrochloride is a new anticancer drug in the treatment of HCC, which is mainly aimed at the pathway of energy metabolism. levamisole may play an anti-tumor role by inhibiting the reverse TCA cycle. The investigators have been proceeding this trial to evaluate the efficacy and safety of arginine hydrochloride combined with levamisole in the treatment of patients with advanced hepatocellular carcinoma.

Conditions
HCC
Being tested
Anlotinib Hydrochloride Capsules, Arginine hydrochloride, levamisole
Keywords
treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib Hydrochloride CapsulesDrug

    Also called AHC

    Anlotinib Hydrochloride Capsules, 12mg/d

  • Arginine hydrochlorideDrug

    Also called AH+AHC

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

  • levamisoleDrug

    Also called AH+AHC+LM

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

Study groups in NCT03950518
Study groupRoleWhat they receive
One-drug RegimesExperimentalDrug: Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;
Receives: Drug: Anlotinib Hydrochloride Capsules
Two-drug RegimesExperimentalAnlotinib Hydrochloride Capsules Arginine hydrochloride
Receives: Drug: Anlotinib Hydrochloride Capsules; Drug: Arginine hydrochloride
Three-drug RegimesExperimentalAnlotinib Hydrochloride Capsules Arginine hydrochloride Levamisole Hydrochloride
Receives: Drug: Anlotinib Hydrochloride Capsules; Drug: Arginine hydrochloride; Drug: levamisole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

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

    Measured: 24 months

Secondary outcomes (1)

  1. Overall Survival

    Time from start of treatment to death from any cause, or last known date of survival

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2019
  2. Study start10 Apr 2019
  3. Primary completion10 Apr 2023 (estimated)
  4. Study completion10 Apr 2023 (estimated)

Resources

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
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03950518
Sponsor's protocol ID
HETCT-002
Acronym
NTAHCC
Status last verified
Apr 2019
First submitted
10 May 2019
Last updated
15 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anlotinib Hydrochloride Capsules, Arginine hydrochloride and levamisole in people with HCC, run by The First Affiliated Hospital of Zhengzhou University 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 15 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: status not confirmed, as of the sponsor's last update on 15 May 2019. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: 24 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 NCT03950518.

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 2019.

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