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Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC

Primary Purpose

Carcinoma; Hepatocellular

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Stereotactic body radiation therapy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma; Hepatocellular focused on measuring Stereotactic Body Radiation Therapy, Recurrent Hepatocellular Carcinoma, Small liver cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Clinical or pathological diagnosis of HCC without lymph node and distant metastasis.

    2. Previous surgery or radiofrequency ablation, no recurrence within 6 months. 3. Early stage liver cancer within Milan criteria : (1) single tumor diameter less than 5 cm; (2) not more than three foci of tumor, each one not exceeding 3 cm; (3) no angioinvasion; (4) no extrahepatic involvement.

    4. The remnant liver volume beyond the radiotherapy target area should be greater than 700ml.

    5. No serious hematological, heart, lung, hepatic, renal dysfunction and immunodeficiency.

    6. Hemoglobin (Hb)≥8g/dL ; white blood cell (WBC) ≥ 2*10^9/L ; neutrophils (ANC) ≥ 1.0* 10^9/L ; platelet (Pt) ≥ 50*10^9/L.

    7. Men or women with fertility are willing to take contraceptive measures in the trial.

    8. ECOG score standard 0 ~ 1 ; child-pugh score A-B . 9. Expected survival period > 3 months. 10. Voluntary participation and signing of informed consent.

Exclusion Criteria:

  • 1. Patients who have undergone antitumor therapy for liver cancer. 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points.

    3. Total bilirubin exceed the upper limit of normal 1.5 times, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 2.5 times, ICGR15≥40%.

    4. Patients undergoing major surgery within 1 month of study initiation. 5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years).

    6. Participants in other clinical trials within 30 days prior to study treatment.

    7. The distance between the tumor and the gastrointestinal tract < 0.5 cm. 8. Pregnancy, lactation or those with fertility but without contraceptive measures.

    9. Patients with drug addiction such as drugs, long-term alcoholism, and AIDS. 10. Patients have an uncontrollable epileptic seizure, or lose insight due to mental illness.

    11. Patients with severe allergic history or specific constitution. 12. Researchers consider it inappropriate to participate in the test.

Sites / Locations

  • The Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic body radiation therapy

Arm Description

Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week.

Outcomes

Primary Outcome Measures

Local control rate（LC）
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)

Secondary Outcome Measures

Short time Safety profile of SBRT
Toxicities appeared during SBRT treatment and up to 3 months after SBRT. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Overall response rate (ORR)
According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%)
Overall survival (OS)
The time between the date of SBRT and death from any cause
Local recurrence rate (LRR)
Rate of intrahepatic hepatocellular carcinoma recurrence
Progression-free survival (PFS)
The time between the date of SBRT and the date of radiographic progression as defined by RECIST1.1

Full Information

First Posted
October 25, 2022
Last Updated
February 15, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05596630
Brief Title
Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC
Official Title
A Single-center, Unblinded, Single-arm, Prospective Trial of Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

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

5. Study Description

Brief Summary
Primary liver cancer is one of the common malignant tumors in China, of which hepatocellular carcinoma (HCC) accounts for 85%-90%. It is worth noting that the recurrence rate of liver cancer is greater than 10% at 1 year after surgery, while the recurrence rate in 5 years reaches 70-80%. Stereotactic body radiation therapy (SBRT) refers to a kind of radiotherapy technology to achieve a steep dose gradient and achieve high-precision position and high-dose fractionated irradiation. The rapid dose drop-down enables SBRT to maximize the protection of normal tissues around the tumor, and it often requires only 1-5 times of high-dose fractionated irradiation to complete the course of treatment.SBRT may play an important role in the treatment of small intrahepatic recurrence HCC, but there is still a lack of evidence of high-level prospective studies. We intend to conduct a single-center, prospective, clinical study to further elaborate the efficacy and safety of SBRT in the treatment of small intrahepatic recurrent HCC.
Detailed Description
Patients with recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chosen for this study. A total of 40 patients will be scheduled to be enrolled. The patients enrolled will be treated with SBRT with no adjuvant therapy, and they will be followed up according to the plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma; Hepatocellular
Keywords
Stereotactic Body Radiation Therapy, Recurrent Hepatocellular Carcinoma, Small liver cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Stereotactic body radiation therapy
Arm Type
Experimental
Arm Description
Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radiation therapy
Intervention Description
Stereotactic body radiotherapy for small intrahepatic recurrent HCC. Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week.
Primary Outcome Measure Information:
Title
Local control rate（LC）
Description
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)
Time Frame
up to 24 months after SBRT
Secondary Outcome Measure Information:
Title
Short time Safety profile of SBRT
Description
Toxicities appeared during SBRT treatment and up to 3 months after SBRT. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
up to 3 months after SBRT
Title
Overall response rate (ORR)
Description
According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%)
Time Frame
up to 24 months after SBRT
Title
Overall survival (OS)
Description
The time between the date of SBRT and death from any cause
Time Frame
up to 24 months
Title
Local recurrence rate (LRR)
Description
Rate of intrahepatic hepatocellular carcinoma recurrence
Time Frame
up to 24 months after SBRT
Title
Progression-free survival (PFS)
Description
The time between the date of SBRT and the date of radiographic progression as defined by RECIST1.1
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Clinical or pathological diagnosis of HCC without lymph node and distant metastasis. 2. Previous surgery or radiofrequency ablation, no recurrence within 6 months. 3. Early stage liver cancer within Milan criteria : (1) single tumor diameter less than 5 cm; (2) not more than three foci of tumor, each one not exceeding 3 cm; (3) no angioinvasion; (4) no extrahepatic involvement. 4. The remnant liver volume beyond the radiotherapy target area should be greater than 700ml. 5. No serious hematological, heart, lung, hepatic, renal dysfunction and immunodeficiency. 6. Hemoglobin (Hb)≥8g/dL ; white blood cell (WBC) ≥ 2*10^9/L ; neutrophils (ANC) ≥ 1.0* 10^9/L ; platelet (Pt) ≥ 50*10^9/L. 7. Men or women with fertility are willing to take contraceptive measures in the trial. 8. ECOG score standard 0 ~ 1 ; child-pugh score A-B . 9. Expected survival period > 3 months. 10. Voluntary participation and signing of informed consent. Exclusion Criteria: 1. Patients who have undergone antitumor therapy for liver cancer. 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points. 3. Total bilirubin exceed the upper limit of normal 1.5 times, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 2.5 times, ICGR15≥40%. 4. Patients undergoing major surgery within 1 month of study initiation. 5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years). 6. Participants in other clinical trials within 30 days prior to study treatment. 7. The distance between the tumor and the gastrointestinal tract < 0.5 cm. 8. Pregnancy, lactation or those with fertility but without contraceptive measures. 9. Patients with drug addiction such as drugs, long-term alcoholism, and AIDS. 10. Patients have an uncontrollable epileptic seizure, or lose insight due to mental illness. 11. Patients with severe allergic history or specific constitution. 12. Researchers consider it inappropriate to participate in the test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weilin Wang, doctor
Phone
+86 0571 87783820
Email
wam@zju.edu.cn
Facility Information:
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
weilin wang
Phone
+86 0571 87783820
Email
wam@zju.edu.cn

12. IPD Sharing Statement

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Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC

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