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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

Treatment of Advanced Intrahepatic Cholangiocarcinoma

Clinicaltrials.gov identifier NCT03940378

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

Study Description

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.

  • Condition or Disease:ICC
  • Intervention/Treatment: Drug: Levamisole Hydrochloride
    Drug: Anlotinib Hydrochloride Capsules
  • Phase: Phase 3
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 152 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: The Efficacy of Levamisole Hcl in Advanced Intrahepatic Cholangiocarcinoma . A Multicenter, Open, Randomized, Prospective Study
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: February 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Two-Drug Regimens
Basic drug: Anlotinib Hydrochloride Capsules Add Intervention drug: Levamisole Hydrochloride
Drug: Levamisole Hydrochloride
Levamisole Hydrochloride Levamisole Hydrochloride 25mg/tablet; 150mg/d; po;

Drug: Anlotinib Hydrochloride Capsules
Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;
Experimental: One-drug Regimes
Basic drug : Anlotinib Hydrochloride Capsules
Drug: Anlotinib Hydrochloride Capsules
Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;
Outcome Measures
  • Primary Outcome Measures: 1. Progression-free Survival [ Time Frame: 24 months ]
    Time from start of treatment until the first documented event of symptomatic progression or death.
  • Secondary Outcome Measures: 1. Overall Survival [ Time Frame: 48 months ]
    Time from start of treatment to death from any cause, or last known date of survival
  • Other Outcome Measures: 1. 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
  • 2. Objective Response Rate(ORR) [ Time Frame: 28 days ]
    Proportion of patients with reduction in tumor burden of a predefined amount
  • 3. The change of AFP biomarker [ Time Frame: approximately 24 months ]
    Concentration of AFP biomarker change in tumor markers
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

- 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 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.

Contacts and Locations

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


China, Henan
The First Affiliated Hospital of Zhengzhou University

Sponsors and Collaborators

The First Affiliated Hospital of Zhengzhou University

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


Principal Investigator: Zujiang Yu The First Affiliated Hospital of Zhengzhou University

More Information
  • Responsible Party: The First Affiliated Hospital of Zhengzhou University
  • ClinicalTrials.gov Identifier: NCT03940378 History of Changes
  • Other Study ID Numbers: LEVICC-001
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Cholangiocarcinoma