A Study of Second-line Treatment With Apatinib for Advanced Intrahepatic Cholangiocarcinoma

Overview

The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.

Full Title of Study: “Single Arm, Exploratory and Open Clinical Trial of Second-line Therapy With Apatinib Mesylate in Advanced Cholangiocarcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2018

Interventions

  • Drug: Apatinib
    • Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.

Arms, Groups and Cohorts

  • Experimental: Apatinib
    • Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.

Clinical Trial Outcome Measures

Primary Measures

  • Disease Control Rate (DCR)
    • Time Frame: 1 month
    • the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease

Secondary Measures

  • Progression-free Survival
    • Time Frame: 24 month
    • Time from start of treatment until the first documented event of symptomatic progression or death.
  • Objective Response Rate(ORR)
    • Time Frame: 1 month, 3 month, 6 month
    • Proportion of patients with reduction in tumor burden of a predefined amount
  • Overall Survival
    • Time Frame: 36 month
    • from start of treatment to death from any cause, or last known date of survival

Participating in This Clinical Trial

Inclusion Criteria

1. Ages 18-65 years;

2. Eastern Cooperative Oncology Group performance score (ECOG): 0-2;

3. Estimated survival time > 3 months;

4. Patients with recurrent or metastatic cholangiocarcinoma with histologic or cytological diagnosis;

5. Previous first-line GP programmes failed, or were not able to withstand first-line treatment;

6. At least one measurable lesion [spiral CT scan ≥ 10 mm (CT scan thickness not greater than 5mm)], Measurable lesions were not treated with radiotherapy or other topical treatments unless progress was achieved after treatment was completed (RECIST version 1.1);

7. Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 75×109/L, HB ≥ 8 g/dL,ALB ≥2.8g/dL,TBIL ≤ 3×ULN, ALT or AST≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Cr clearance ≥ 50 mL/min;Thyroid function is normal;

8. No serious history of drug allergy;

9. Subjects volunteered for the study. Sign informed consent, good compliance, with follow-up.

Exclusion Criteria

1. Patients have received targeted therapy;

2. Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction);

3. Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment;

4. Urine routine showed that urine protein ≥++ or the urine protein in 24 hours>1.0 g;

5. Pregnant or lactating women;

6. History of other malignancy within 5 years except for effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma and / or effectively excised orthotopic cervical and / or breast cancer;

7. The researchers judged other conditions that might affect clinical research and the outcome of the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First Affiliated Hospital of Zhengzhou University
  • Collaborator
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wei He, Deputy Chief Physician of Oncology – The First Affiliated Hospital of Zhengzhou University
  • Overall Official(s)
    • Wei He, Principal Investigator, The First Affiliated Hospital of Zhengzhou University
  • Overall Contact(s)
    • Wei He, 18638553286, hewei726@126.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.