Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer

NCT07325565 | Recruiting

• 1 other identifier: CHALLENGE-03
• Study Type: observational
• Target: 651
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) carries a poor prognosis, with limited efficacy from current therapies including immune checkpoint inhibitors (ICIs). Concurrently, emotional distress (ED) is highly prevalent in cancer patients and is implicated in tumor progression via neuroendocrine-immune axis dysregulation (e.g., HPA axis activation, immunosuppressive TME). Emerging evidence, particularly from lung cancer, suggests ED may adversely impact ICI efficacy. However, its specific role and clinical significance in HCC, especially regarding ICI response, remain poorly understood. To address this gap, we propose a large-scale, prospective, multicenter, multi-cohort study to systematically evaluate the impact of ED on treatment outcomes in HCC patients receiving immunotherapy.

Conditions

Emotional Disorder; Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  In the three cohorts, PFS following immunotherapy was compared between primary liver cancer patients with and without emotional disorders.

  From date of enrollment until the date of first progress or date of death from any cause, whichever came first, assessed up to 60 months.

Secondary Outcomes (1)

• Overall survival(OS)

  From date of enrollment until the date of death from any cause, assessed up to 96 months.

Study Arms (3)

Advanced unresectable HCC cohort

Cohort 1: Impact of ED on first-line therapy for advanced, unresectable HCC (n=243)

Other: Scale score

Advanced unresectable ICC cohort

Cohort 2: Impact of ED on first-line therapy for advanced, unresectable intrahepatic cholangiocarcinoma (ICC) (n=175)

Other: Scale score

Resectable high-risk HCC cohort

Cohort 3: Impact of ED on postoperative recurrence in resectable high-risk HCC (n=233)

Other: Scale score

Interventions

Scale score OTHER

* The PHQ-9 rating scale and GAD-7 rating scale were used to screen for depression and anxiety symptoms in cancer patients; * The PSQI was used to assess the sleep quality index of cancer patients; ③ The PHQ-9 rating scale and GAD-7 rating scale were used to evaluate the depression and anxiety status of patient caregivers; ④ The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) was used to assess the quality of life of cancer patients.

Advanced unresectable HCC cohort; Advanced unresectable ICC cohort; Resectable high-risk HCC cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll adult patients with newly diagnosed, treatment-naïve, unresectable HCC or ICC who are scheduled to receive guideline-recommended first-line immunotherapy-based regimens. Eligible participants must have at least one radiologically measurable lesion per RECIST 1.1 criteria, preserved liver function, and a good performance status. This population is designed to evaluate the impact of baseline emotional distress on immunotherapy outcomes in a representative cohort of patients with primary liver cancer initiating standard-of-care treatment.

You may qualify if:

• Age between 18 and 75 years, inclusive, regardless of gender.
• Presence of at least one radiologically measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (defined as a lesion with a longest diameter of ≥10 mm on CT scan).
• Newly diagnosed, treatment-naïve patients with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).
• Child-Pugh liver function score ≤ 7.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Absence of severe organic diseases affecting the heart, lungs, brain, or other major organs.

You may not qualify if:

• History of other malignancies.
• Recurrent HCC.
• Prior systemic therapy for HCC.
• Hepatic decompensation.
• History of severe psychiatric disorders.
• Current use of antidepressant or anxiolytic medication.
• Inability to comprehend or complete the assessment questionnaires.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Lysholm Knee Score

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Central Study Contacts

Wanguang Zhang

CONTACT

13886195965; wgzhang@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

CN (1)