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

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Guoliang Jiang, Shanghai Proton and Heavy Ion Center
Sponsor:
Information provided by (Responsible Party):
Guoliang Jiang, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT02946138
First received: October 25, 2016
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Hepatocellular Carcinoma Radiation: carbon-ion radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Guoliang Jiang, Shanghai Proton and Heavy Ion Center:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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] ]
  • Objective responses rate [ Time Frame: 3 months ]

Estimated Enrollment: 44
Study Start Date: October 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02946138

Contacts
Contact: Zheng Wang, Dr. +86-021-38296666 ext 53609 zheng.wang@sphic.org.cn
Contact: Wei-xiang Qi, Dr. weixiang.qi@sphic.org.cn

Locations
China, Shanghai
Shanghai Proton and Heavy Ion Center Recruiting
Shanghai, Shanghai, China, 201321
Contact: zheng wang, MD    +86-021-38296666-53609    zheng.wang@sphic.org.cn   
Contact: weixiang Qi, MD    +86-021-38296666-53609    weixiang.qi@sphic.org.cn   
Principal Investigator: guoliang Jiang, Prof.         
China
Shanghai Proton and Heavy Ion Center Recruiting
Shanghai, China, 201321
Contact: zheng wang, MD    +86-021-38296666-53609    zheng.wang@sphic.org.cn   
Contact: weixiang Qi, MD    +86-021-38296666-53609    weixiang.qi@sphic.org.cn   
Principal Investigator: guoliang Jiang, Prof.         
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Principal Investigator: guo-liang jiang, Dr. Shanghai Proton and Heavy Ion Center
  More Information

Responsible Party: Guoliang Jiang, Director the committee of clinical technique, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02946138     History of Changes
Other Study ID Numbers: SPHIC-TR-HCC2016-02
Study First Received: October 25, 2016
Last Updated: October 27, 2016
Individual Participant Data  
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:
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

ClinicalTrials.gov processed this record on June 23, 2017