Phase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma

NCT ID: NCT02946138

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-08-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

carbon-ion radiotherapy with GM-CSF

Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gray(Gy) \[relative biological effectiveness (RBE)\] in 5 fractions for intrahepatic cases away from gastro-intestinal (GI) tract (\>1cm) with concurrent GM-CSF 125ug/m2/d, subcutaneous injection d1-28;

Group Type: EXPERIMENTAL

carbon-ion radiotherapy

Intervention Type: RADIATION

Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions

Interventions

carbon-ion radiotherapy

Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions

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. 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;

• 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

guo-liang jiang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Proton and Heavy Ion Center

Locations

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Shanghai Proton and Heavy Ion Center

Shanghai, , China

Countries

China

Other Identifiers

SPHIC-TR-HCC2016-02

Identifier Type: -

Identifier Source: org_study_id