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Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
carbon-ion radiotherapy for tumor away from GI
carbon-ion radiotherapy for tumor adjacent to GI
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, carbon-ion radiotherapy, toxicity, efficacy

Eligibility Criteria

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

Inclusion Criteria:

  1. histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases (AASLD)-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein (AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association;
  2. no clinically distant metastasis;
  3. Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm;
  4. age ≥ 18 and <80 years of age;
  5. Karnofsky Performance Score ≥ 70;
  6. No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial;
  7. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

Exclusion Criteria:

  1. Distant metastasis (M1);
  2. maximal tumor size is more than 12 cm;
  3. tumor invading adjacent gastrointestine (T4);
  4. Child push score B or C;
  5. Previous hepatic radiotherapy;
  6. Severe systemic disorders;
  7. Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer;
  8. Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
  9. Psychiatric disorders or any other condition that can make unreliable the informed consent;

Sites / Locations

  • Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

carbon-ion radiotherapy for tumor away from GI

carbon-ion radiotherapy for tumor adjacent to GI

Arm Description

For tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels [55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx] are planned within the Phase I part.

For tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Overall survival of all patients
Overall survival of all patients
Progression-free survival of all patients
Progression-free survival of all patients
Number of participants with tumor response as assessed by RECIST 1.1
Number of participants with tumor response as assessed by RECIST 1.1

Full Information

First Posted
June 12, 2016
Last Updated
November 21, 2021
Sponsor
Shanghai Proton and Heavy Ion Center
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1. Study Identification

Unique Protocol Identification Number
NCT02802124
Brief Title
Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
Official Title
Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma
Detailed Description
The purpose of this study is to determine the maximal tolerated dose (MTD) of carbon ion radiotherapy (CIRT) in the treatment of localized Chinese hepatocellular carcinoma with respective to toxicity and tumor control. Participants will be treated with CIRT with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 3 months after the completion of CIRT. Primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, carbon-ion radiotherapy, toxicity, efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
carbon-ion radiotherapy for tumor away from GI
Arm Type
Experimental
Arm Description
For tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels [55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx] are planned within the Phase I part.
Arm Title
carbon-ion radiotherapy for tumor adjacent to GI
Arm Type
Experimental
Arm Description
For tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part.
Intervention Type
Radiation
Intervention Name(s)
carbon-ion radiotherapy for tumor away from GI
Intervention Type
Radiation
Intervention Name(s)
carbon-ion radiotherapy for tumor adjacent to GI
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Time interval from the start of CIRT to 3 months after the completion of CIRT
Secondary Outcome Measure Information:
Title
Overall survival of all patients
Description
Overall survival of all patients
Time Frame
From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Title
Progression-free survival of all patients
Description
Progression-free survival of all patients
Time Frame
From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Title
Number of participants with tumor response as assessed by RECIST 1.1
Description
Number of participants with tumor response as assessed by RECIST 1.1
Time Frame
Time interval from the start of CIRT to 3 months after the completion of CIRT

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: histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases (AASLD)-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein (AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association; no clinically distant metastasis; Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm; age ≥ 18 and <80 years of age; Karnofsky Performance Score ≥ 70; No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial; Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial; Exclusion Criteria: Distant metastasis (M1); maximal tumor size is more than 12 cm; tumor invading adjacent gastrointestine (T4); Child push score B or C; Previous hepatic radiotherapy; Severe systemic disorders; Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer; Non conformity of the radiotherapy dose distribution when compared to the dose constraints; Psychiatric disorders or any other condition that can make unreliable the informed consent;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Wang, MD
Phone
+86-38296666-53609
Email
zheng.wang@sphic.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhan Yu, MD
Phone
+86-38296666-53607
Email
zhan.yu@sphic.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
guoliang Jiang, Prof.
Organizational Affiliation
Shanghai Proton and Heavy Ion Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201321
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zheng wang, MD
Phone
+86-021-38296666-53609
Email
zheng.wang@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Zhan Yu, MD
Phone
+86-021-38296666-53609
Email
zhan.yu@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
guoliang Jiang, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

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