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

Phase 2

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Drug: Apatinib

• Registration Number: NCT03521219
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-07
• Study First Submitted: 2018-04-21
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-09
• Last Update Submitted: 2018-05-09
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-11
• Primary Completion: 2018-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China