NCT01192971

Brief Summary

This phase II trial will be studying how well Apatinib working in patients with Hepatocellular carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

August 30, 2010

Last Update Submit

March 1, 2023

Conditions

Advanced Hepatocellular Carcinoma

Keywords

HCC, Apatinib, phase II, Cancer

Outcome Measures

Primary Outcomes (1)

  • TTP (Time to Progression)

    8 weeks

Secondary Outcomes (5)

  • Overall Survival

    8 weeks

  • DCR (Disease control rate

    8 weeks

  • ORR (objective response rate)

    8 weeks

  • Serum alpha-fetoprotein (AFP) level

    8 weeks

  • QoL (quality of life): EORTC QLQ-C30

    8 weeks

Study Arms (2)

A: 850mg

EXPERIMENTAL

A: Experimental apatinib 850 mg qd p.o, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: Apatinib

B: 750mg

EXPERIMENTAL

B: Apatinib 750 qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: Apatinib

Interventions

ApatinibDRUG

apatinib p.o. once daily for 4 weeks

A: 850mgB: 750mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologic confirmed advanced hepatocellular carcinoma
  • Patients who are unable to or unwilling to undergo surgery or interventional procedures via hepatic artery, or patients who have relapsed/progressed after surgery or interventional procedure via hepatic artery for ≥ 4 weeks and are unable to use sorafenib.
  • Life expectancy of more than 12 weeks.
  • ECOG performance scale 0 - 2.
  • Child -Pugh score A，BCLC stage B or C.
  • At least one therapy naïve measurable lesion (larger than 10 mm in diameter by spiral CT scan, conforming to RECIST 1.1).
  • Have not received systemic chemotherapy or molecular targeted therapy. At least 4 weeks must have elapsed for patients who have previously underwent radiotherapy or surgery, and all the adverse drug reactions (ADRs) or wounds have completely healed. At least 6 months must have elapsed for patients who have received adjuvant chemotherapy.
  • Adequate organ functions (hemoglobin≥ 90g/L ,platelets ≥80 × 109/L, neutrophil≥ 1.5 × 109/L, albumin ≥ 29 g/L, Plasma creatinine ≤ 1.5 × ULN , ALT and AST\< 5 × ULN; TBIL ≤ 1.5 × ULN.
  • Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

You may not qualify if:

  • Pregnant or lactating women.
  • Patients with known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma; other malignancies previously or currently, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
  • Dysphagia, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption.
  • Evidence of CNS metastasis.
  • Subjects with hypertension which cannot be well controlled by antihypertensives; grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmia, and cardiac insufficiency grades III to IV according to NYHA criteria; cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) of \< 50%.
  • Subjects with abnormal coagulation functions, and the tendency of bleeding or those who are currently treated by a thrombolytic or anticoagulant therapy.
  • Definite concern of gastrointestinal hemorrhage, and history of gastrointestinal hemorrhage within 6 months.
  • Patients with symptomatic ascites requiring therapeutic paracentesis or drainage, or with a Child-Pugh score of ≥ 2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Millitary Eighty-one Hosiptal

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

apatinib

Study Officials

  • Shukui Qin, Dr

    Nanjing Millitary Eighty-one Hosiptal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 1, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 3, 2023

Record last verified: 2023-02

Locations

CN(1)