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Treatment of Advanced Intrahepatic Cholangiocarcinoma (TAICC)

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ClinicalTrials.gov Identifier: NCT03940378
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
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
Information provided by (Responsible Party):
Zujiang YU, The First Affiliated Hospital of Zhengzhou University

Study Description
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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 Intervention/treatment Phase
ICC Drug: Levamisole Hydrochloride Drug: Anlotinib Hydrochloride Capsules 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
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Study Type : Interventional  (Clinical Trial)
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 1, 2019
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: One-drug Regimes
Basic drug : Anlotinib Hydrochloride Capsules
 Drug: Anlotinib Hydrochloride Capsules
Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;
Other Name: AHC
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;
Other Name: LH

Drug: Anlotinib Hydrochloride Capsules
Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;
Other Name: AHC


Outcome Measures
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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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940378


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

Locations
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China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450000
Contact: Zujiang Yu, pro    0086-0371-67966942    johnyuem@zzu.edu.cn   
Contact: Juan Li, pro    0086-0371-67966942    ananli1984@126.com   
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
Investigators
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Principal Investigator: Zujiang Yu The First Affiliated Hospital of Zhengzhou University
More Information
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Responsible Party: Zujiang YU, The director of infectious diseases department, 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Levamisole
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents