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

Single Arm, Exploratory and Open Clinical Trial of Second-line Therapy With Apatinib Mesylate in Advanced Cholangiocarcinoma

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

Study Overview

• Status: Unknown
• Conditions: Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Wei He

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib; Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.	Drug: Apatinib; Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Wei He, The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: April 21, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: AHEAD-HNP050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No