Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma

Browse trials for

• Carcinoma 6,766
• Carcinoma, Hepatocellular 3,174

Study arms

• Experimental
  Suspension Group

  Patients are treated with chemoembolization using a formulation that consists of a suspension of 100mg pure anhydrous cisplatin in 20mL Lipiodol (5mg cisplatin /mL suspension)

  Procedure: Lipiodol-based transarterial chemoembolization

• Active comparator
  Emulsion Group

  Patients are treated with chemoembolization using a formulation that consists of 10mg aqueous cisplatin (10mL) mixed with 10mL Lipiodol to form an emulsion (0.5mg cisplatin/mL emulsion)

  Procedure: Lipiodol-based transarterial chemoembolization

Interventions

• ProcedureLipiodol-based transarterial chemoembolization

  Arterial catheterization to segmental, subsegmental, or sub-subsegmental level was achieved depending on the tumor size, to gain arterial access as close to the tumors as possible. The formulation was delivered under fluoroscopic control until the vasculature of all tumors was entirely filled, or until the maximum dose was reached.

  Also known as: Conventional chemoembolization, cTACE

Primary outcomes

1. Number of Paticipants With Complete Tumor Response After the First 3 Treatments

   Complete tumor response is defined according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria as well as DSA findings during the second and third treatment, it is defined as the absence of enhancing tumor on CT and/ or absence of residual tumor on selective DSA of the feeding arteries to the tumors and absence of enhancing tumor on the subsequent CT.

   Time frame: Within 6 months after randomization

2. Number of Participants With Severe Adverse Events of All Treatment Procedures Occurring Within 30 Days of the Treatment

   Severe adverse events is defined as any undesirable symptom, sign or medical condition which was fatal or life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or was medically significant, might jeopardize the patient and might require medical or surgical intervention.

   Time frame: within 30 days of the treatment

Secondary outcomes

1. Number of Paticipants With Complete Tumour Response After the First Treatment

   Complete tumor response is defined according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria as well as DSA findings during the second and third treatment, it is defined as the absence of enhancing tumor on CT and/ or absence of residual tumor on selective DSA of the feeding arteries to the tumors and absence of enhancing tumor on the subsequent CT.

   Time frame: At 3 months after the first treatment

2. Number of Participants With Complete or Partial Tumour Response at 6 Months

   Objective tumor response was defined as complete response or partial response. Partial response was defined by the modified RECIST criteria as at least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions

   Time frame: At 6 months after the first treatment

3. Number of Participants With Intralesional Tumour Progression From Randomization Date up to 78 Months

   Intralesional tumor progression is defined as tumor recurrence at the site of treated tumor after initial complete tumor response, or any degree of enlargement of treated tumor after initial partial response;

   Time frame: throughout follow-up period, up to 78 months

4. Number of Participants With Extralesional Tumour Progression From Randomization Date up to 78 Months

   Extralesional tumor progression is defined as occurrence of new tumor at a new site of the liver;

   Time frame: throughout follow-up period, up to 78 months

5. Number of Participants With Extrahepatic Tumour Progression up to 78 Months

   Extrahepatic tumor progression is defined as occurrence of venous invasion by tumor or extrahepatic tumor metastasis;

   Time frame: throughout follow-up period, up to 78 months

6. Time Interval in Months From Randomization Date to Occurrence of Any Kind of Tumor Progression up to 78 Months

   Any kind of tumor progression include intralesional progression, extralesional progression, or extrahepatic progression

   Time frame: throughout follow-up period, up to 78 months

7. Progression Free Survival in Number of Months up to 78 Months

   Progression free survival is defined as the interval between the randomization date and the date of any kind of tumor progression or death from any cause;

   Time frame: throughout follow-up period, up to 78 months

8. Overall Survival in Months up to 78 Months

   Overall survival Overall survival is defined as the interval between the randomization date and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive;

   Time frame: throughout follow-up period, up to 78 months

9. Adverse Event

   Number of participants with the specific adverse event that occurred within 30 days after the first treatment

   Time frame: Within 30 days after the first treatment

10. Serious Adverse Event

    Serious adverse event that occurs within 30 days after all treatments

    Time frame: Within 30 days after all treatments

Baseline characteristics

Study documents

• Study protocol · Jul 16, 2016
• Statistical analysis plan · Jul 16, 2016
• Informed consent form · Jul 16, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No