Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

NCT02802124 | Terminated DMC

• 1 other identifier: SPHIC-TR-HCC2016-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; carbon-ion radiotherapy; toxicity; efficacy

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Time interval from the start of CIRT to 3 months after the completion of CIRT

Secondary Outcomes (3)

• Overall survival of all patients

  From the diagnosis of localized hepatocellular carcinoma, a median of 2 years

• Progression-free survival of all patients

  From the diagnosis of localized hepatocellular carcinoma, a median of 2 years

• Number of participants with tumor response as assessed by RECIST 1.1

  Time interval from the start of CIRT to 3 months after the completion of CIRT

Study Arms (2)

carbon-ion radiotherapy for tumor away from GI

EXPERIMENTAL

For tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels \[55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx\] are planned within the Phase I part.

Radiation: carbon-ion radiotherapy for tumor away from GI

carbon-ion radiotherapy for tumor adjacent to GI

EXPERIMENTAL

For tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part.

Radiation: carbon-ion radiotherapy for tumor adjacent to GI

Interventions

carbon-ion radiotherapy for tumor away from GI RADIATION

carbon-ion radiotherapy for tumor away from GI

carbon-ion radiotherapy for tumor adjacent to GI RADIATION

carbon-ion radiotherapy for tumor adjacent to GI

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;
• Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 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 12 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 (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 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

• guoliang Jiang, Prof.

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director the committee of clinical technique

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 16, 2016
• Study Start: June 1, 2015
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)