ICCPhase 3TAICCNCT03940378

Treatment of Advanced Intrahepatic Cholangiocarcinoma

A Phase 3 study testing Levamisole Hydrochloride and Anlotinib Hydrochloride Capsules in people with ICC, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 Levamisole Hcl in the treatment of patients with advanced intrahepatic cholangiocarcinoma. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: ICC
What is being tested?: Levamisole Hydrochloride and Anlotinib Hydrochloride Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteChina
Study dates: 1 Feb 2019to 1 Feb 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)
a.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.

Zujiang Yu, pro contact

0086-0371-67966942

johnyuem@zzu.edu.cn

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: The Efficacy of Levamisole Hcl in Advanced Intrahepatic Cholangiocarcinoma . A Multicenter, Open, Randomized, Prospective Study

The purpose of this study is to evaluate the efficacy and safety of Levamisole Hcl in the treatment of patients with advanced intrahepatic cholangiocarcinoma.

Read the detailed description

Intrahepatic cholangiocarcinoma(ICC) ,a kind of Hepatocellular carcinoma, is the sixth most common cancer and thesecond leading cause of cancer-related deaths in the world.Currently, Surgical resection is still the main treatment methods of early the ICC, but that is high recurrent . Levamisole Hcl is a broad spectrum of intestinal worm medicine, our previous study have found levamisole could significantly promote the apoptosis of bile duct cancer cells, restrain the progress of the bile duct carcinoma in clinic and prolong survival time.This drug is applicable to a variety of reasons caused by intrahepatic bile duct carcinoma and extrahepatic bile duct carcinoma,so we carry out the study to evaluate the efficacy and safety of Levamisole Hcl in the treatment of patients with advanced intrahepatic cholangiocarcinoma.

Conditions: ICC
Being tested: Levamisole Hydrochloride, Anlotinib Hydrochloride Capsules

What participants receive

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

Levamisole HydrochlorideDrug
Also called LH
Levamisole Hydrochloride Levamisole Hydrochloride 25mg/tablet; 150mg/d; po;
Anlotinib Hydrochloride CapsulesDrug
Also called AHC
Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;

Study groups in NCT03940378
Study group	Role	What they receive
One-drug Regimes	Experimental	Basic drug : Anlotinib Hydrochloride Capsules Receives: Drug: Anlotinib Hydrochloride Capsules
Two-Drug Regimens	Experimental	Basic drug: Anlotinib Hydrochloride Capsules Add Intervention drug: Levamisole Hydrochloride Receives: Drug: Levamisole Hydrochloride; Drug: Anlotinib Hydrochloride Capsules

What is being measured

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

Progression-free Survival
Time from start of treatment until the first documented event of symptomatic progression or death.
Measured: 24 months

Secondary outcomes (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 Feb 20191 Feb 2023

First posted7 May 2019
Study start1 Feb 2019
Primary completion1 Feb 2023 (estimated)
Study completion1 Feb 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ICCStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 152 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03940378
Sponsor's protocol ID: LEVICC-001
Acronym: TAICC
Status last verified: May 2019
First submitted: 9 Apr 2019
Last updated: 7 May 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Levamisole Hcl in Advanced Intrahepatic Cholangiocarcinoma . A Multicenter, Open, Randomized, Prospective Study
ClinicalTrials.gov ID: NCT03940378
Acronym / sponsor ID: TAICC / LEVICC-001
Conditions: ICC
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 152 participants (estimated)
Lead sponsor: The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
Collaborators: First Affiliated Hospital of Xinjiang Medical University, Luoyang Central Hospital, Nanyang Central Hospital, Anyang Tumor Hospital, Third People's Hospital of Jiaozuo, Sanmenxia Central Hospital, pinmei Group General Hospital
Study start: 1 Feb 2019 (actual)
Primary completion: 1 Feb 2023 (estimated)
Study completion: 1 Feb 2023 (estimated)
First posted: 7 May 2019 (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.

The purpose of this study is to evaluate the efficacy and safety of Levamisole Hcl in the treatment of patients with advanced intrahepatic cholangiocarcinoma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
One-drug Regimes	Experimental	Drug: Anlotinib Hydrochloride CapsulesBasic drug : Anlotinib Hydrochloride Capsules
Two-Drug Regimens	Experimental	Drug: Levamisole Hydrochloride, Drug: Anlotinib Hydrochloride CapsulesBasic drug: Anlotinib Hydrochloride Capsules Add Intervention drug: Levamisole Hydrochloride

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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)

Key exclusion criteria (18 listed)

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)

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
Levamisole HydrochlorideAlso: LHLevamisole Hydrochloride Levamisole Hydrochloride 25mg/tablet; 150mg/d; po;	Drug	Two-Drug Regimens
Anlotinib Hydrochloride CapsulesAlso: AHCAnlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;	Drug	One-drug Regimes, Two-Drug Regimens

Primary outcome

Progression-free Survival
Time frame: 24 months
Time from start of treatment until the first documented event of symptomatic progression or death.

1 secondary outcome

Overall Survival
Time frame: 48 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.

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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.

Zujiang Yu, pro contact

0086-0371-67966942

johnyuem@zzu.edu.cn

Zujiang Yu principal investigator

The First Affiliated Hospital of Zhengzhou University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levamisole Hydrochloride and Anlotinib Hydrochloride Capsules in people with ICC, 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 7 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?

Contact Zujiang Yu, pro (0086-0371-67966942, johnyuem@zzu.edu.cn), or a site near the patient. 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 NCT03940378.

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 7 May 2019.