Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Shanghai Proton and Heavy Ion Center

Status: Terminated

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: carbon-ion radiotherapy for tumor away from GI; Radiation: carbon-ion radiotherapy for tumor adjacent to GI

Study type: Interventional

Funder types: Other

Identifiers

NCT02802124

SPHIC-TR-HCC2016-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

carbon-ion radiotherapy for tumor away from GI

Experimental group

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.

Treatment:

Radiation: carbon-ion radiotherapy for tumor away from GI

carbon-ion radiotherapy for tumor adjacent to GI

Experimental group

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.

Treatment:

Radiation: carbon-ion radiotherapy for tumor adjacent to GI