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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03521219
• Other study ID #: AHEAD-HNP050
• Status: Recruiting
• Phase: Phase 2
• Start date: February 7, 2018
• Est. completion date: November 2019

Study information

• Verified date: May 2018
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Wei He
• Phone: 18638553286
• Email: hewei726[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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