Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of MHCC

NCT03243916 | Unknown

• 1 other identifier: ChinaPLAGH-MHCC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma is a highly malignant tumor that is progressing rapidly. Hepatic arterial embolization chemotherapy (TACE) is a common method for the treatment of unresectable of hepatocellular carcinoma.But for patients with \> 10cm hepatocellular carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic radiotherapy which can track the movement of tumor and monitor the position deviation of tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

interventional therapy; TACE; Cyberknife

Outcome Measures

Primary Outcomes (2)

• response rate(RR)

  CR(complete response)+PR(partial response)

  18 months

• overall survival(OS)

  Overall survival was defined as the time from enrollment to death from any cause.

  26mounth

Secondary Outcomes (2)

• adverse event(AE)

  36 month

• Quality of life (QOL)

  36 month

Study Arms (1)

combination

EXPERIMENTAL

TACE plus cyber knife

Radiation: TACE plus Cyber knife

Interventions

TACE plus Cyber knife RADIATION

Patients with histologically confirmed MHCC(Massive Hepatocellular Carcinoma) will receive TACE therapy,after 1 or 2 week's recovery from hepatic insufficiency ,the targeted and staged cyber knife will be given

combination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed hepatocellular carcinoma
• No lymph node metastasis or distant metastasis
• Tumor diameter at least 10 cm
• Hepatic lesions are not suitable for surgical resection or the patient refuse to surgical treatment
• Eastern Clinical Oncology Group (ECOG)score is 0， 1or2
• No history of abdominal radiotherapy
• Inoperable and untransplantable,Child-pugh score A or B
• Normal liver volume exceeds 700 cm3

You may not qualify if:

• Previous history of abdominal radiotherapy;
• The maximum diameter of tumor is less than 10cm;
• The liver Child is graded C;
• Contraindication for radiotherapy;
• Active gastrointestinal bleeding occurred within 2 weeks before enrollment
• Pregnancy
• Undergoing chemotherapy throughout the past six months
• Diffuse hepatocellular carcinoma
• Main portal vein tumor embolization
• Undergoing other simultaneous treatment

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA Gereral Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Yu Li, MD

  China PLA hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoliang liu, MD

CONTACT

+86 15801570739; szy957@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Department of Radiotherappy

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 9, 2017
• Study Start: August 15, 2017
• Primary Completion: July 14, 2019
• Study Completion: July 14, 2020
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

CN (1)