Clinical trial NCT03116984: A Study of Comparison of TACE Combination With and Without EBRT for Advanced HCC
Official title: A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for HCC Which is Unresectable But Confined to the Liver
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
external- beam radiotherapy (EBRT)
transarterial chemoembolization (TACE)
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Shanghai 10th People's Hospital
name: First Affiliated Hospital of Zhejiang University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Fujian Cancer Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Zhongshan Hospital Xiamen University
name: West China Hospital
name: Peking University Cancer Hospital & Institute
name: Xinqiao Hospital of Chongqing
name: 309th Hospital of Chinese People's Liberation Army
name: Heilongjiang Provincial Agricultural Reclamation General Hospital
name: Longyan First Hospital, Affiliated to Fujian Medical University
name: Peking University First Hospital
name: The Third Affiliated Hospital of Qiqihar Medical Universitiy
name: Anhui Provincial Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Qingdao University
name: The 4th people's hospital of Wuxi City, Affiliated to Jiangnan University
name: Subei People's Hospital of Jiangsu Province,Yangzhou University
name: The Affiliated Zhongshan Hospital of Dalian University
name: Jilin University
name: First Affiliated Hospital of Guangxi Medical University
name: Fudan University
name: Shanghai East Hospital,Tongji University School of Medicine
name: Chinese PLA General Hospital
name: The 4th People's Hospital of Linfen City
name: Nanfang Hospital, Southern Medical University
name: Yunnan Cancer Hospital
name: Shandong Cancer Hospital and Institute
name: Sichuan Cancer Hospital and Research Institute
name: First Affiliated Hospital, Sun Yat-Sen University
name: The Second Affiliated Hospital of Chongqing Medical University
name: Fujian Medical University Union Hospital
name: The People's Hospital of Hunan Province
First posted: 2017-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is a prospective, randomized, controlled and multicenter study.And the trial is going to better control intrahepatic tumors for hepatocellular carcinoma(HCC) patients who meet the inclusion criterion.The patients were divided into two groups, the group A by TACE and the other group B by external- beam radiotherapy(EBRT) after 2 times TACE. Then the therapeutic effects and toxicities of TACE and EBRT are evaluated during the follow-up period. The study design plans to enroll 300 patients, and each group includes 150 cases.

Detailed description: Enrolled HCC patients met the inclusion criterion, in the late or advanced stage,tumor confined in intrahepatic( meet the tolerance-dose for the liver), without cancer embolus in main branch of portal vein, without extrahepatic metastasis and the number of tumor was≤3. Eligible participants will be randomly assigned to the group A by TACE and the other group B by EBRT after 2 times TACE.

TACE group: The frequency of treatment is determined based on the disease condition for patients who are randomly assigned to group of TACE.TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery, and micro-embolization superselective catheterization is preferred.Adriamycin(30 to 60mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion.The dose of fluid lipiodol was determined by diameter and blood supply type of HCC,generally 5-20ml, and no more than 30ml once.The boundary is considered whether there are large amounts of lipiodol to deposit in the tumor and tiny branches shadow of portal veins in paracarcinoma under fluoroscopic guidance. Embolizing agents(gelatin sponge particles 350um-560um) are added after lipiodol emulsion embolization.It has a possibility of observeation alone if tumor achieves a complete response after two times TACE.

EBRT group: Patients who were randomized to the radiotherapy group start radiotherapy 3-5 weeks after the completion 2 times TACE and began to undergo radiation. Radiotherapy equipment is based on the conditions of the cooperative units. 3-dimensional conformal radiation therapy(3-DCRT), intensity-modulated radiation therapy(IMRT) or Image-Guided Radiotherapy(IGRT) will be opted based on hospital. IGRT can also be used via helical tomotherapy, Rapid Arc or Volumetric Modulated Arc Therapy(VMAT). The target volume should include the visible tumor.

Eligibility criteria: 1. Inclusion Criteria 1）initially diagnosed HCC (confirmed by pathology or meet clinical diagnostic criteria), 2）The patients are not candidates for curative surgery, which should be determined in consultation with two oncology surgeons of the same center, 3）Tumor was confined in intrahepatic( meet the tolerance-dose for the liver), without cancer embolus in main branch of portal vein, without extrahepatic metastasis and the number of tumor was≤3, 4）Child-Pugh A，white blood cell count \>2\*109/L、Hb\>90g/L、PLT\>50\*109/L, 5）The score of Eastern Cooperative Oncology Group(ECOG): 0-2, 6）The estimated survival time \> 3 months, 7）Without midsection history of radiation therapy, 8）Age: \>18 years old, 9）Informed consent was signed.
2. Exclusion Criteria 1）Diffuse hepatocellular carcinoma, 2）Uncontrollable infection, 3）Concurrent other malignant tumors, 4）Simultaneously participate in other experimental drugs or clinical trials, 5）Serious of heart, lung and kidney diseases, 6）During pregnancy and lactation, 7) The ones with severe neurologic morbidity couldn't clearly tell therapeutic response.
3. Halfway exit criteria 1）Do not treat according to the research or seriously violate the fundamental principles after enrolled, 2）Cannot tolerate radiation therapy, including the ones that cann't complete the radiation treatment( the dose \<40 Gy,biological effective dose \<48 Gy), or interrupt more than 2 weeks during radiotherapy, 3）Unwilling to continue this clinical trial.

Primary outcomes:
measure: 3-year overall survival(OS)
timeFrame: The outcome measures are assessed up to three years.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Fudan University, Shanghai, China
name: Zhongshan Hospital
role: STUDY_DIRECTOR
References: