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

Phase 2

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: carbon-ion radiotherapy

• Registration Number: NCT02946138
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
carbon-ion radiotherapy with GM-CSF	carbon-ion radiotherapy	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;

Primary Outcome Measures

Name	Time	Method
Progression-free survival of all patients	2 year	Time in months measured from treatment initiation until the date of progression or the date of last follow-up.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 year	Time in months measured from treatment initiation until the date of death or the date of last follow-up.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy]
Objective responses rate	3 months

Trial Locations

Locations (1)

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