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

NCT05638438 | Unknown

• 1 other identifier: 2022-KY-180-01
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Hepatocellular Carcinoma Non-resectable

Outcome Measures

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

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

Secondary Outcomes (6)

• disease control rate (DCR)

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

• The progression-free survival rate (PFSR)

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

• The overall survival rate (OSR)

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

• The progression-free survival time (mPFS)

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

• The median overall survival time (mOS)

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

Interventions

transarterial therapies PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Unresectable Hepatocellular Carcinoma

You may qualify if:

• clinically or histopathologically diagnosed HCC;
• not suitable for curative surgery, or local ablation;
• age 18\~75 years；
• 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.;
• ）no serious heart, lung, or renal dysfunction； 8）at least 1 measurable lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)

You may not qualify if:

• ）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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Interventions

donafenib; spartalizumab

Study Officials

• Mingxin Pan, Prof.

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingxin Pan, Prof.

CONTACT

18928918216; pmxwxy@sohu.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 6, 2022
• Study Start: December 2, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-11