Clinical trial · Observational

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

Efficacy and Safety of the Combination of Transarterial Therapies With Donafenib Plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma: A Retrospective Real-world Study

NCT05638438CI-TRIAL-00062525unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This Retrospective Real-world study was designed to evaluate the clinical efficacy and safety of the Combination of transarterial therapies with donafenib plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hepatocellular Carcinoma Non-resectable	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
transarterial therapies	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
the objective response rate (ORR)
timeFrame
From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
description
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

Secondary outcomes (6)

measure
disease control rate (DCR)
timeFrame
From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
description
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
measure
The progression-free survival rate (PFSR)
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. clinically or histopathologically diagnosed HCC;
2. not suitable for curative surgery, or local ablation;
3. age 18\~75 years；
4. Barcelona Clinic Liver Cancer (BCLC) Stage-B or C HCC; 5) Child-Pugh score A or B7; 6) Eastern Cooperative Group (ECOG) performance status ≤1.;

7）no serious heart, lung, or renal dysfunction； 8）at least 1 measurable lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)

Exclusion Criteria:

1）comorbidity with other severe systemic diseases; 2）life expectancy is less than 3 months; 3) discontinuation of treatment for personal reasons or inability to tolerate; 4）incomplete data.

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References

Publications (0)

Data not yet available

No reference posted for this study.