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TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma

Primary Purpose

Liver Tumor

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TACE combined with Lenvatinib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Tumor focused on measuring Large hepatocellular carcinoma, Lenvatinib, TACE, Microwave ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months;
  • Number of tumors ≤ 3;
  • Large hepatocellular carcinoma with tumor diameter ≥ 7 cm;
  • Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus;
  • Although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked;
  • Child Pugh grade A or B of liver function; ECoG physical fitness score < 2;
  • No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment;
  • Leukocyte count ≥ 3.0 × 109/L；
  • Hemoglobin ≥ 8.5g/dl;
  • Platelet count ≥ 50 × 109/L；
  • The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin time (PT) does not exceed the upper limit of normal control for 3 seconds;
  • Serum creatinine was less than 1.5 times of the upper limit of normal;
  • Patients and / or family members agree to join the clinical trial and sign the informed consent form

Exclusion Criteria:

  • Diffuse hepatocellular carcinoma;
  • Portal vein tumor thrombus;
  • Combined with tumor thrombus of hepatic vein and inferior vena cava;
  • Patients with lymph node metastasis and extrahepatic distant metastasis;
  • The liver function was classified as child Pugh C and could not be improved by liver protection treatment;
  • Arteriovenous fistula or arterioportal fistula with ineffective intervention;
  • Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obvious bleeding tendency;
  • Intractable massive ascites;
  • ECoG physical fitness score > 2 points;
  • Combined with active infection, especially bile duct inflammation;
  • Serious heart, lung, kidney, brain and other important organ diseases;
  • Note: see attached table 1 for child Pugh classification of liver function; See attached table 2 for ECoG physical fitness score

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TACE combined with Lenvatinib

Arm Description

Three days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg).

Outcomes

Primary Outcome Measures

Down stage rate
if the patient achieve any of these three criteria： ① the patient was downgraded from BCLC stage C to BCLC stage B (portal branch tumor thrombus was inactive, the focus was less than or equal to 7cm; or the focus did not invade the surrounding tissue after shrinking) or Milan standard (single tumor diameter was not more than 5cm or less than or equal to 3 tumors, and the maximum diameter was not more than 3cm, without vascular invasion). ② Liver function reaches child Pugh grade A or B; ③ The patient is in good health and can tolerate ablation.

Secondary Outcome Measures

RFS
Recurrence free survival indicates the length of time after MWA for a cancer ends that the patient survives without any signs or symptoms of HCC
Objective response rate
Change of the tumor size according to the modified response evaluation criteria in solid tumors (mRECIST) [see attached table 3], the efficacy is defined as CR (complete remission), PR (partial remission), SD (stable) and PD (Progress)
Changes of liver and kidney function
Changes of liver and kidney function index from blood biochemistry compared to baseline
TACE frequency and ablation frequency
To access the times and frequency of TACE and ablation

Full Information

First Posted
January 20, 2022
Last Updated
September 23, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05555316
Brief Title
TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
Official Title
Prospective Single Arm Phase II Study of TACE Combined With Lenvatinib and MWA After Down-stage in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the treatment of advanced liver cancer. After successful down-stage, radical microwave ablation was further performed.
Detailed Description
The purpose of this study is to explore the objective effective rate of TACE combined with Lenvatinib in the treatment of locally advanced liver cancer, so as to provide a new idea for the radical microwave ablation treatment mode after the decline of locally advanced liver cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Tumor
Keywords
Large hepatocellular carcinoma, Lenvatinib, TACE, Microwave ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TACE combined with Lenvatinib
Arm Type
Experimental
Arm Description
Three days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg).
Intervention Type
Drug
Intervention Name(s)
TACE combined with Lenvatinib
Other Intervention Name(s)
lenvima
Intervention Description
Three days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg). Lenvatinib reduction standard: 8mg / day; 4mg / day; 4mg, the next day.
Primary Outcome Measure Information:
Title
Down stage rate
Description
if the patient achieve any of these three criteria： ① the patient was downgraded from BCLC stage C to BCLC stage B (portal branch tumor thrombus was inactive, the focus was less than or equal to 7cm; or the focus did not invade the surrounding tissue after shrinking) or Milan standard (single tumor diameter was not more than 5cm or less than or equal to 3 tumors, and the maximum diameter was not more than 3cm, without vascular invasion). ② Liver function reaches child Pugh grade A or B; ③ The patient is in good health and can tolerate ablation.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
RFS
Description
Recurrence free survival indicates the length of time after MWA for a cancer ends that the patient survives without any signs or symptoms of HCC
Time Frame
3 years
Title
Objective response rate
Description
Change of the tumor size according to the modified response evaluation criteria in solid tumors (mRECIST) [see attached table 3], the efficacy is defined as CR (complete remission), PR (partial remission), SD (stable) and PD (Progress)
Time Frame
3 years
Title
Changes of liver and kidney function
Description
Changes of liver and kidney function index from blood biochemistry compared to baseline
Time Frame
3 years
Title
TACE frequency and ablation frequency
Description
To access the times and frequency of TACE and ablation
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months; Number of tumors ≤ 3; Large hepatocellular carcinoma with tumor diameter ≥ 7 cm; Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus; Although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked; Child Pugh grade A or B of liver function; ECoG physical fitness score < 2; No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment; Leukocyte count ≥ 3.0 × 109/L； Hemoglobin ≥ 8.5g/dl; Platelet count ≥ 50 × 109/L； The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin time (PT) does not exceed the upper limit of normal control for 3 seconds; Serum creatinine was less than 1.5 times of the upper limit of normal; Patients and / or family members agree to join the clinical trial and sign the informed consent form Exclusion Criteria: Diffuse hepatocellular carcinoma; Portal vein tumor thrombus; Combined with tumor thrombus of hepatic vein and inferior vena cava; Patients with lymph node metastasis and extrahepatic distant metastasis; The liver function was classified as child Pugh C and could not be improved by liver protection treatment; Arteriovenous fistula or arterioportal fistula with ineffective intervention; Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obvious bleeding tendency; Intractable massive ascites; ECoG physical fitness score > 2 points; Combined with active infection, especially bile duct inflammation; Serious heart, lung, kidney, brain and other important organ diseases; Note: see attached table 1 for child Pugh classification of liver function; See attached table 2 for ECoG physical fitness score
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinhua Huang, Ph.D
Phone
0086-20-87343447
Email
huangjh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhua Huang, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhua Huang, Ph.D
Phone
0086-20-87343447
Email
huangjh@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Jinhua Huang, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma

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