Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02802124
• Other study ID #: SPHIC-TR-HCC2016-01
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: October 2023

Study information

• Verified date: November 2023
• Source: Shanghai Proton and Heavy Ion Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• carbon-ion radiotherapy for tumor away from GI

• carbon-ion radiotherapy for tumor adjacent to GI

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival of all patients	Overall survival of all patients	From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Secondary	Progression-free survival of all patients	Progression-free survival of all patients	From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Secondary	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