Clinical trial NCT02946138: Phase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma
Official title: A Prospective Phase II Single-institution Trial of Carbon-ion Radiotherapy Combined With Granulocyte-macrophage Colony-stimulating Factor for the Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
carbon-ion radiotherapy
GM-CSF
immunotherapy
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this research project is to assess the efficacy and toxicity of hypofractionated carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for the treatment of hepatocellular carcinoma

Detailed description: Golden E.B. et al.in 2015 reported that localized radiotherapy granulocyte-macrophage colony-stimulating factor (GM-CSF) produced objective abscopal responses in solid tumor with metastasises. We hypothesize that hypofractionated carbon-ion radiotherapy combining granulocyte-macrophage colony-stimulating factor (GM-CSF) might improve the clinical response rate and progression-free survival (PFS) in hepatocellular carcinoma. The primary endpoint of the current phase II trial is progression-free survival rate at 2 years, secondary endpoints are overall survival, safety and toxicity.

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. the tumor is away from gastro-intestinal (GI) tract (\>1cm);
4. Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 10 cm;
5. age ≥ 18 and \<80 years of age;
6. Karnofsky Performance Score ≥ 70;
7. 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;
8. 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 10 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: Progression-free survival of all patients
timeFrame: 2 year
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 year
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy]
measure: Objective responses rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: guo-liang jiang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: