Clinical trial NCT02802124: Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
Official title: Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
carbon-ion radiotherapy
toxicity
efficacy
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Time interval from the start of CIRT to 3 months after the completion of CIRT
Secondary outcomes:
measure: Overall survival of all patients
timeFrame: From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
measure: Progression-free survival of all patients
timeFrame: From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
measure: Number of participants with tumor response as assessed by RECIST 1.1
timeFrame: Time interval from the start of CIRT to 3 months after the completion of CIRT
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: guoliang Jiang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: