Clinical trial
A Randomized, Open-label, Phase 3 Trial Evaluating Adjuvant Transarterial Chemoembolization for TNM Stage I and II Hepatocellular Carcinoma Recurrence After Curative Resection
Name
2014-103
Description
1. Hepatocellular carcinoma (HCC) is the most common primary malignancy of liver, representing the third leading cause of cancer-related death worldwide.
2. Its overall dismal prognosis is a result of high incidence rates of metastasis and postoperative recurrence, in particular the intrahepatic recurrence.
3. TACE is the most widely used primary treatment for unresectable HCC. It was also used as the optional treatment for relapsed disease. However, the efficacy of TACE used as adjuvant therapy following hepatectomy remains controversial.
Trial arms
Trial start
2014-03-26
Estimated PCD
2023-05-13
Trial end
2023-05-13
Status
Completed
Phase
Early phase I
Treatment
Prophylactic Transcatheter Arterial Chemoembolization
Participants enrolled in the adjuvant TACE group received one to two cycles of TACE with an interval of 4\~6 weeks, and the first TACE was given within 1 week after randomization.
Arms:
Adjuvant TACE
Observation
Participants enrolled in the observation group were subjected to active surveillance without any adjuvant treatment.
Arms:
Observation
Size
332
Primary endpoint
RFS(Recurrence free survival)
the time from randomization to the first documented HCC recurrence by independent radiological assessment or death due to any cause, whichever occurred first，assessed up to 120 months
Eligibility criteria
Inclusion Criteria:
* Pathological diagnosis of HCC (AJCC stage I or II)
* Without recurrence in 1 month postoperation
* Must be tolerant to TACE
Exclusion Criteria:
* With intrahepatic recurrence postoperation
* Insufficient liver function
* Stage III or IV
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After confirming eligibility by the investigators, patients without residual tumors on the CT/MRI were consented and randomly assigned in a 1:1 ratio into the adjuvant TACE group or the observation group. Allocation of treatment group was done with a computer-generated random number list.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 332, 'type': 'ACTUAL'}}
Updated at
2024-05-29
1 organization
1 product
2 indications
Organization
Zhejiang UniversityIndication
Hepatocellular CarcinomaIndication
Transcatheter Arterial Chemoembolization