Treatment of Advanced Intrahepatic Cholangiocarcinoma

NCT ID: NCT03940378

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2023-02-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One-drug Regimes

Basic drug : Anlotinib Hydrochloride Capsules

Group Type: EXPERIMENTAL

Anlotinib Hydrochloride Capsules

Intervention Type: DRUG

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

Two-Drug Regimens

Basic drug: Anlotinib Hydrochloride Capsules Add Intervention drug: Levamisole Hydrochloride

Group Type: EXPERIMENTAL

Levamisole Hydrochloride

Intervention Type: DRUG

Levamisole Hydrochloride Levamisole Hydrochloride 25mg/tablet; 150mg/d; po;

Anlotinib Hydrochloride Capsules

Intervention Type: DRUG

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

Interventions

Levamisole Hydrochloride

Levamisole Hydrochloride Levamisole Hydrochloride 25mg/tablet; 150mg/d; po;

Intervention Type: DRUG

Anlotinib Hydrochloride Capsules

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

Intervention Type: DRUG

Other Intervention Names

LH; AHC

Eligibility Criteria

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:

1. 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#

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role: collaborator

Luoyang Central Hospital

OTHER

Sponsor Role: collaborator

Nanyang Central Hospital

OTHER

Sponsor Role: collaborator

Anyang Tumor Hospital

OTHER

Sponsor Role: collaborator

Third People's Hospital of Jiaozuo

UNKNOWN

Sponsor Role: collaborator

Sanmenxia Central Hospital

UNKNOWN

Sponsor Role: collaborator

pinmei Group General Hospital

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zujiang YU

The director of infectious diseases department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zujiang Yu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zujiang Yu, pro

Role: CONTACT

johnyuem@zzu.edu.cn

0086-0371-67966942

Facility Contacts

Zujiang Yu, pro

Role: primary

johnyuem@zzu.edu.cn

0086-0371-67966942

Juan Li, pro

Role: backup

ananli1984@126.com

0086-0371-67966942

Other Identifiers

LEVICC-001

Identifier Type: -

Identifier Source: org_study_id