Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Not Applicable

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: carbon-ion radiotherapy for tumor adjacent to GI; Radiation: carbon-ion radiotherapy for tumor away from GI

• Registration Number: NCT02802124
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-12
• Study First Posted: 2016-06-16
• Primary Completion: 2023-10
• Study Completion: 2023-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbon-ion radiotherapy for tumor adjacent to GI	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.
carbon-ion radiotherapy for tumor away from GI	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival of all patients	From the diagnosis of localized hepatocellular carcinoma, a median of 2 years	Overall survival of all patients
Progression-free survival of all patients	From the diagnosis of localized hepatocellular carcinoma, a median of 2 years	Progression-free survival of all patients
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	Number of participants with tumor response as assessed by RECIST 1.1

Trial Locations

Locations (1)

Shanghai Proton and Heavy Ion Center; 🇨🇳 Shanghai, Shanghai, China