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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

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2019)
Progression-free Survival [ Time Frame: 24 months ]
Time from start of treatment until the first documented event of symptomatic progression or death.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2019)
Overall Survival [ Time Frame: 48 months ]
Time from start of treatment to death from any cause, or last known date of survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 4, 2019)
  • 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
  • Objective Response Rate(ORR) [ Time Frame: 28 days ]
    Proportion of patients with reduction in tumor burden of a predefined amount
  • The change of AFP biomarker [ Time Frame: approximately 24 months ]
    Concentration of AFP biomarker change in tumor markers
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment of Advanced Intrahepatic Cholangiocarcinoma
Official Title  ICMJE The Efficacy of Levamisole Hcl in Advanced Intrahepatic Cholangiocarcinoma . A Multicenter, Open, Randomized, Prospective Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ICC
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: One-drug Regimes
    Basic drug : Anlotinib Hydrochloride Capsules
    Intervention: Drug: Anlotinib Hydrochloride Capsules
  • Experimental: Two-Drug Regimens
    Basic drug: Anlotinib Hydrochloride Capsules Add Intervention drug: Levamisole Hydrochloride
    Interventions:
    • Drug: Levamisole Hydrochloride
    • Drug: Anlotinib Hydrochloride Capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2019)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2023
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zujiang Yu, pro 0086-0371-67966942 johnyuem@zzu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940378
Other Study ID Numbers  ICMJE LEVICC-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zujiang YU, The First Affiliated Hospital of Zhengzhou University
Study Sponsor  ICMJE The First Affiliated Hospital of Zhengzhou University
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Zujiang Yu The First Affiliated Hospital of Zhengzhou University
PRS Account The First Affiliated Hospital of Zhengzhou University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP