A Single-arm Clinical Study of HAIC Combined With Apatinib and Camrelizumab in the Treatment of Unresectable MTM HCC

Sponsor
Wan-Guang Zhang
Study ID
NCT05839197
Phase
PHASE2
Status
Unknown

Conditions

  • Macrotrabecular Massive Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HAIC — PROCEDURE
    administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.
  • Camrelizumab plus Apatinib — DRUG
    Apatinib(250 mg; p.o.; qd.); camrelizumab (200 mg; iv drip; q3w) If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC.

Study Details

This is a single-arm, open, multicenter II phase clinical study to compare the efficacy and safety of HAIC combined with Apatinib and Camrelizumab in the treatment of unresectable middle-advanced MTM-HCC.

Key Dates

Start date
May 5, 2023
Status verified
Dec 2023
Primary completion
Apr 15, 2025
Completion
Apr 15, 2025

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HAIC Combined With Apatinib and Camrelizumab
    All patients were treated with standard HAIC on the first day (D1). Immediately after the first HAIC, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC. The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study.

Primary Outcome Measure

Objective remission rate (ORR) [ Time Frame: After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 1 year ]

Central Contacts