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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946138
Recruitment Status : Withdrawn (enrollment was too slow)
First Posted : October 27, 2016
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Guoliang Jiang, 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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation: carbon-ion radiotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: 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;
Radiation: carbon-ion radiotherapy
Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions




Primary Outcome Measures :
  1. Progression-free survival of all patients [ Time Frame: 2 year ]
    Time in months measured from treatment initiation until the date of progression or the date of last follow-up.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 year ]
    Time in months measured from treatment initiation until the date of death or the date of last follow-up.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy] ]
  3. Objective responses rate [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946138


Locations
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China, Shanghai
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai, China, 201321
China
Shanghai Proton and Heavy Ion Center
Shanghai, China, 201321
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
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Principal Investigator: guo-liang jiang, Dr. Shanghai Proton and Heavy Ion Center
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Responsible Party: Guoliang Jiang, Director the committee of clinical technique, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02946138    
Other Study ID Numbers: SPHIC-TR-HCC2016-02
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Guoliang Jiang, Shanghai Proton and Heavy Ion Center:
Hepatocellular Carcinoma
carbon-ion radiotherapy
GM-CSF
immunotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases