A Study of Comparison of TACE Combination With and Without EBRT for Advanced HCC

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 300
• Participant gender: All

Summary

This clinical trial is a prospective, randomized, controlled and multicenter study.And the trial is going to enroll 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: 309th Hospital of Chinese People's Liberation Army; affiliated Zhongshan hospital of Dalian university; Anhui Provincial Hospital; Beijing Cancer Hospital; Changhai Hospital; First Affiliated Hospital of Fujian Medical University; First Affiliated Hospital of Guangxi Medical University; First Affiliated Hospital of Xinjiang Medical University; First Affiliated Hospital of Zhejiang University; Fudan University; Fujian Cancer Hospital; Heilongjiang Provincial Agricultural Reclamation General Hospital; Jilin University; Longyan First Hospital, Affiliated to Fujian Medical University; Peking University First Hospital; Qingdao University; Shanghai 10th People's Hospital; Subei People's Hospital of Jiangsu Province,Yangzhou University; The 4th people's hospital of Wuxi City,Affiliated to Jiangnan Universit; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Xiamen University; The Third Affiliated Hospital of Qiqihar Medical Vniversitiy; West China Hospital; Xinqiao Hospital of Chongqing; Zhongshan Hospital Xiamen University
• Treatments: Chlorotrianisene; Doxorubicin; Ethiodized Oil; Liposomal doxorubicin
• Last Updated: 2017-12-05

Criteria

1. Inclusion Criteria 1）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, without extrahepatic metastasis and macro-vascular invasion (secondary vascular branches or below it), and the number of tumor was≤3 , 4）Child-Pugh A，normal renal function including serum creatinine and urea nitrogen level, white blood cell count >3×109/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）Informed consent was signed, 9）Age: from 18 to 75 years old.

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 dose <40 Gy,biological effective dose (BED)<48 Gy, and interrupt more than 2 weeks during radiotherapy, 3）Unwilling to continue this clinical trial.