Hepatocellular Carcinoma Clinical Trial
— TACE-EBRTOfficial 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
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | 180 Fenglin Road | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital | 309th Hospital of Chinese People's Liberation Army, Anhui Provincial Hospital, Beijing Cancer Hospital, Changhai Hospital, Chinese PLA General 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, First Affiliated Hospital, Sun Yat-Sen University, Fudan University, Fujian Cancer Hospital, Fujian Medical University Union Hospital, Heilongjiang Provincial Agricultural Reclamation General Hospital, Jilin University, Longyan First Hospital, Affiliated to Fujian Medical University, Nanfang Hospital of Southern Medical University, Peking University First Hospital, Qingdao University, Shandong Cancer Hospital, Shanghai 10th People's Hospital, Shanghai East Hospital,Tongji University School of Medicine, Sichuan Cancer Hospital and Research Institute, Subei People's Hospital of Jiangsu Province,Yangzhou University, The 4th People's Hospital of Linfen City, The 4th people's hospital of Wuxi City, Affiliated to Jiangnan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Zhongshan Hospital of Dalian University, The People's Hospital of Hunan Province, The Second Affiliated Hospital of Chongqing Medical University, The Third Affiliated Hospital of Qiqihar Medical Universitiy, West China Hospital, Xinqiao Hospital of Chongqing, Yunnan Provinical Cancer Hospital, Zhongshan Hospital Xiamen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year overall survival(OS) | The therapeutic effects are mainly evaluated by the 3-year overall survival(OS). | The outcome measures are assessed up to three years. |
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