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

NCT02946138 | Withdrawn Phase 2 DMC

• 1 other identifier: SPHIC-TR-HCC2016-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; carbon-ion radiotherapy; GM-CSF; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival of all patients

  Time in months measured from treatment initiation until the date of progression or the date of last follow-up.

  2 year

Secondary Outcomes (3)

• Overall Survival

  2 year

• 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

Study Arms (1)

carbon-ion radiotherapy with GM-CSF

EXPERIMENTAL

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

Interventions

carbon-ion radiotherapy RADIATION

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

carbon-ion radiotherapy with GM-CSF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• no clinically distant metastasis;
• the tumor is away from gastro-intestinal (GI) tract (\>1cm);
• Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 10 cm;
• age ≥ 18 and \<80 years of age;
• Karnofsky Performance Score ≥ 70;
• 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;
• Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

You may not qualify if:

• Distant metastasis (M1);
• maximal tumor size is more than 10 cm;
• tumor invading adjacent gastrointestine (T4);
• Child push score B or C;
• Previous hepatic radiotherapy;
• Severe systemic disorders;
• 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;
• Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
• Psychiatric disorders or any other condition that can make unreliable the informed consent;

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (2)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201321, China

Location

Shanghai Proton and Heavy Ion Center

Shanghai, 201321, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• guo-liang jiang, Dr.

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director the committee of clinical technique

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 27, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)