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For tumor locates away from GI the planned enrolled patient had been completed, but for tumor locates closely to GI only 6 patients had been enrolled because not many eligible patients were available.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbon-ion radiotherapy for tumor away from GI | Experimental | 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. |
|
| carbon-ion radiotherapy for tumor adjacent to GI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon-ion radiotherapy for tumor away from GI | Radiation |
| ||
| carbon-ion radiotherapy for tumor adjacent to GI |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| guoliang Jiang, Prof. | Shanghai Proton and Heavy Ion Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Shanghai | Shanghai Municipality | 201321 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Radiation |
|
| 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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |