HAIC + Atezolizumab Plus Bevacizumab in Unresectable HCC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRenJi Hospital
About this trial
Patients with unresectable HCC will be enrolled in the cohort and will receive the combination therapy of HAIC and atezolizumab plus bevacizumab. The objective response rate is the primary endpoint, and the secondary endpoint includes disease control rate, conversion rate, pathologic complete response, major pathologic response, progression-free survival, recurrence-free survival, overall survival, quality of life, and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients between 18 and 75 years old, with no gender restrictions.
Confirmed unresectable hepatocellular carcinoma (BCLC stage B/C) by histology, cytology, or clinical diagnosis.
At least one measurable lesion based on RECIST version 1.1.
Child-Pugh class A or B7.
Disqualifiers
Known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, sarcomatoid HCC, or fibrolamellar carcinoma.
Concurrent autoimmune diseases, organ/hematopoietic stem cell transplantation history, or other malignancies.
Impaired consciousness, inability to cooperate with treatment, or active psychiatric disorders.
Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), bevacizumab, molecular targeted therapy, atezolizumab, or other PD-1/PD-L1 inhibitors received before enrollment.
Trial population
Patients who is diagnosed as unresectable hepatocellular carcinoma (BCLC stage B/C) histologically , cytologically, or clinically.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
28 Participants
are grouped into 1 trial groupGroup A: Experimental cohort
Trial outcomes
Primary outcomes
1
Objective Response Rate
Complete response (CR) and partial response (PR), refer to cases evaluated by the mRECIST criteria for objective tumor response, including both CR and PR.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov
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