Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: carbon-ion radiotherapy for tumor away from GI
* Radiation: carbon-ion radiotherapy for tumor adjacent to GI


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbon-ion radiotherapy for tumor away from GI<br>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. | Radiation: carbon-ion radiotherapy for tumor away from GI<br> <br> |
| Experimental: carbon-ion radiotherapy for tumor adjacent to GI<br>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. | Radiation: carbon-ion radiotherapy for tumor adjacent to GI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Time interval from the start of CIRT to 3 months after the completion of CIRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of all patients | Overall survival of all patients | From the diagnosis of localized hepatocellular carcinoma, a median of 2 years | 
| Progression-free survival of all patients | Progression-free survival of all patients | From the diagnosis of localized hepatocellular carcinoma, a median of 2 years | 
| Number of participants with tumor response as assessed by RECIST 1.1 | Number of participants with tumor response as assessed by RECIST 1.1 | Time interval from the start of CIRT to 3 months after the completion of CIRT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toxicity, carbon-ion radiotherapy, efficacy, hepatocellular carcinoma