Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

NCT ID: NCT02802124

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2023-10-31

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; carbon-ion radiotherapy; toxicity; efficacy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

carbon-ion radiotherapy for tumor away from GI

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.

Group Type: EXPERIMENTAL

carbon-ion radiotherapy for tumor away from GI

Intervention Type: RADIATION

carbon-ion radiotherapy for tumor adjacent to GI

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.

Group Type: EXPERIMENTAL

carbon-ion radiotherapy for tumor adjacent to GI

Intervention Type: RADIATION

Interventions

carbon-ion radiotherapy for tumor away from GI

Intervention Type: RADIATION

carbon-ion radiotherapy for tumor adjacent to GI

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: lead

Responsible Party

Guoliang Jiang

Director the committee of clinical technique

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

guoliang Jiang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Proton and Heavy Ion Center

Locations

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SPHIC-TR-HCC2016-01

Identifier Type: -

Identifier Source: org_study_id