The Synergistic Effect of Portal Venous Supply Control and Immunotherapy in Hepatocellular Carcinoma

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05760430
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PVE+cTACE+Camrelizumab+Apatinib — COMBINATION_PRODUCT
    After cTACE, 3 mg/kg of Camrelizumab was injected intravenously once every three weeks+250 mg of Apatinib mesylate tablets were taken orally once a day. PVE was performed on the half liver with the largest tumor load 2 weeks after CTACE.
  • cTACE+Atirizumab+Bevacizumab — COMBINATION_PRODUCT
    After cTACE, 1200 mg of Atirizumab+15 mg/kg of Bevacizumab was injected intravenously every three weeks.

Study Details

Hepatocellular carcinoma is one of the most common solid malignant tumors. The prognosis of unresectable hepatocellular carcinoma is very poor. According to the current literature and the clinical practice of our center, portal vein blood supply control may have great potential in the synergistic treatment of unresectable hepatocellular carcinoma. Thus, we hope to study the safety and efficacy of portal blood supply control +TACE+ Camrelizumab + Apatinib combined therapy in initial unresectable hepatocellular carcinoma through a single-center clinical trial, and explore the synergistic effect of portal blood flow control in target immune therapy of hepatocellular carcinoma.

Key Dates

Start date
Dec 14, 2022
Status verified
Dec 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    After cTACE, 3 mg/kg of Camrelizumab was injected intravenously once every three weeks+250 mg of Apatinib mesylate tablets were taken orally once a day. PVE was performed on the half liver with the largest tumor load 2 weeks after CTACE.
  • Active Comparator: Control group
    After cTACE, 1200 mg of Atirizumab+15 mg/kg of Bevacizumab was injected intravenously every three weeks.

Primary Outcome Measure

Conversion rate [ Time Frame: The time frame is from the first treatment to the last treatment, an average of 2 years. ]

Central Contacts

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