Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study

Browse trials for

• Carcinoma 6,741
• Carcinoma, Hepatocellular 3,182

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 100 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Lead sponsor

Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.

Study population

Interventions

• Proceduretransarterial therapies

  transarterial therapies combine with donafenib and Anti-PD-1 Antibody

  Also known as: donafenib, Anti-PD-1 Antibody

Primary outcomes

1. the objective response rate (ORR)

   ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST

   Time frame: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)

Secondary outcomes

1. disease control rate (DCR)

   DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST

   Time frame: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)

2. The progression-free survival rate (PFSR)

   PFSR is defined as the percentage of participants who have not accured disease progression or death at the time of 6 or 12 months as assessed by RECIST 1.1 and mRECIST

   Time frame: From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first (max 24 months)

3. The overall survival rate (OSR)

   OSR is defined as the percentage of participants who still alive at the time of 6 or 12 months.

   Time frame: From date of begining triplet therapy to the date of first documentation of death from any cause, whichever occurs first (max 24 months)

4. The progression-free survival time (mPFS)

   The progression-free survival time (mPFS) defined as the time from begining triplet therapy to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST

   Time frame: From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first(max 24 months)

5. The median overall survival time (mOS)

   OS is measured from the start date of the Treatment (date of begining triplet therapy) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.

   Time frame: From the start date of the Treatment until date of death from any cause (max 24 months)

6. Adverse events

   Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

   Time frame: From the begining triplet therapy until date of death from any cause (max 24 months)