Impact of Emotional Status on Prognosis of Patients With BCLC Stage B/C Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University

About this trial

This study is a multicenter, prospective, observational clinical trial designed to evaluate the impact of baseline emotional status on the clinical outcomes of patients with BCLC stage B/C hepatocellular carcinoma undergoing HAIC combined with targeted immunotherapy. A total of 90 patients are planned to be enrolled and divided into a depressive mood group and a non-depressive mood group based on a PHQ-9/GAD-7 score of ≥5 points. The primary study endpoint is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety profile. Dynamic assessments of patients' emotional status, quality of life (EORTC QLQ-C30), and peripheral blood levels of neuroendocrine-immune markers will be conducted at preset time points. The results indicate that emotional status may serve as an important modifiable factor influencing the efficacy of comprehensive therapy in patients with advanced liver cancer, providing an evidence-based basis for the formulation of psychosomatic integrated clinical intervention strategies in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1: All patients provided voluntary, written informed consent prior to any study procedures.

Disqualifiers

None

Trial population

This study aims to evaluate the impact of baseline emotional status on clinical outcomes in patients with BCLC stage B/C hepatocellular carcinoma receiving HAIC combined with targeted and immunotherapy, providing an evidence-based foundation for developing future clinical strategies integrating physical and mental health interventions.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 2 trial groups
Group A: ED
Group B: no ED

Trial outcomes

Primary outcomes

1

progression free survival

Time frame
Baseline(day 1), and after every two treatment cycles(up to 2 years).

Secondary outcomes

1

Objective response rate

Time frame
Baseline(day 1), and after every two treatment cycles(up to 2 years).
2

Overall Survival

Time frame
Baseline(day 1), and after every two treatment cycles(up to 2 years).
3

Disease Control Rate

Time frame
Baseline(day 1), and after every two treatment cycles(up to 2 years).

Other outcomes

Sponsors and contacts

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