The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study

NCT07141056 | Recruiting DMC

• 1 other identifier: 2024IITLL-51
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. The study aims to answer whether having emotional distress before treatment or changes in emotional distress during treatment affect how well immunotherapy works to treat liver cancer. Researchers will compare participants with and without emotional distress to examine differences in how long the cancer stays under control, treatment response, and overall survival time. Study participants will complete mood and quality of life questionnaires, meet with mental health specialists for emotional assessments, undergo regular blood tests to measure stress hormones, have routine medical check-ups and scans to monitor their cancer status, and be followed for up to 3 years. The study includes three groups of people with liver cancer: those starting immunotherapy for cancer that cannot be removed by surgery, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. To be eligible for participation, individuals must be 18 years or older, diagnosed with liver cancer, about to start immunotherapy treatment, and able to complete mood questionnaires.

Conditions

HCC - Hepatocellular Carcinoma; Psychological Distress; Immune Checkpoint Inhibitors (ICIs); Cancer, Treatment-Related; Unresectable Hepatocellular Carcinoma

Keywords

Observational Study; Hepatocellular Carcinoma (HCC); Emotional Distress; Immune Checkpoint Inhibitors; Cancer Immunotherapy

Outcome Measures

Primary Outcomes (3)

• Progression-Free Survival (PFS)

  Time from treatment initiation to disease progression or death

  Up to 24 months

• Disease-Free Survival (DFS)

  Time from surgery to disease recurrence or death

  Up to 36 months

• Pathological Complete Response (pCR) Rate

  Percentage of participants achieving complete pathological response

  At time of surgery (approximately 6-8 weeks after neoadjuvant therapy)

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to 36 months

• Objective Response Rate (ORR)

  Up to 2 years (assessed every 6-8 weeks from from treatment initiation until disease progression or death from any cause)

• Stress Biomarker Levels

  From baseline up to 36 months (assessed every 3 months until study completion, disease progression, or death from any cause, whichever occurs first)

• Safety and Adverse Events

  Throughout study duration (up to 36 months)

• Health-Related Quality of Life measured by EORTC QLQ-C30 Total Score

  Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years).

Other Outcomes (1)

• Association between stress biomarkers and treatment response

  Baseline, every 3 months during treatment, and up to 3 years follow-up

Study Arms (3)

Cohort 1: Unresectable HCC First-line ICI

This group includes participants with unresectable hepatocellular carcinoma who will receive first-line immune checkpoint inhibitor therapy. Participants must have BCLC stage B or C disease and Child-Pugh score A or B (≤7). They will receive standard-of-care immune checkpoint inhibitor therapy according to their physician's choice, either as monotherapy or in combination with other treatments. Emotional distress will be assessed before treatment initiation and during therapy using standardized questionnaires and clinical evaluations. Treatment response will be evaluated every 6-8 weeks using mRECIST criteria.

Other: Psychological Stress Status

Cohort 2: Resectable HCC Adjuvant ICI

This group includes participants with resectable hepatocellular carcinoma who have undergone curative surgery and will receive adjuvant immune checkpoint inhibitor therapy. They will begin immune checkpoint inhibitor therapy within 4-6 weeks after surgery. Emotional distress will be assessed before starting adjuvant therapy and during treatment. Disease-free survival will be monitored through regular follow-up visits and imaging.

Other: Psychological Stress Status

Cohort 3: Resectable HCC Neoadjuvant ICI

This group includes participants with resectable hepatocellular carcinoma who will receive immune checkpoint inhibitor therapy before planned surgery. They will receive immune checkpoint inhibitor therapy before surgery, with response assessed using mRECIST criteria. Emotional distress will be evaluated before and during treatment. Pathological complete response will be assessed in surgical specimens.

Other: Psychological stress status

Interventions

Psychological stress status OTHER

Psychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up.

Cohort 1: Unresectable HCC First-line ICI

Eligibility Criteria

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

Study Population

The study population consists of adult patients diagnosed with hepatocellular carcinoma (HCC) who are candidates for immune checkpoint inhibitor therapy. This includes three distinct groups: patients with unresectable HCC who are eligible for first-line immunotherapy (BCLC stage B or C disease), patients with surgically resected HCC who are candidates for adjuvant immunotherapy and patients with potentially resectable HCC who are candidates for neoadjuvant immunotherapy . The study will enroll participants regardless of gender, ethnicity, socioeconomic status, education level, or insurance status. A total of 700 participants will be enrolled across all three cohorts from multiple tertiary hospitals.

You may qualify if:

• Age ≥ 18 years
• Able to complete psychological questionnaires
• Child-Pugh liver function class A
• ECOG performance status ≤ 1
• Signed informed consent
• Expected survival \> 3 months
• Diagnosed with unresectable HCC by pathology or imaging
• BCLC stage B or C
• Has at least one measurable lesion (mRECIST)
• About to receive first-line ICI treatment

You may not qualify if:

• Currently taking antidepressant or anti-anxiety medications
• Previous diagnosis of psychiatric disorders
• Concurrent malignancy
• Unable to complete psychological assessments
• Previous systemic anti-tumor therapy
• Symptomatic brain metastases
• Child-Pugh score \> 7
• Cohort 2 (SOLACE-2):
• Age ≥ 18 years
• Able to complete psychological questionnaires
• Child-Pugh liver function class A
• ECOG performance status ≤ 1
• Signed informed consent
• Expected survival \> 3 months
• Pathologically confirmed HCC after curative surgery

Sponsors & Collaborators

• Guilin Medical University, China: lead
• the Affiliated hospital of Guilin medical university, China: collaborator

Study Sites (5)

The Second Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524000, China

RECRUITING

The Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541001, China

RECRUITING

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541001, China

RECRUITING

Shaoyang Central Hospital

Shaoyang, Hunan, 422000, China

RECRUITING

The First Affiliated Hospital of Shaoyang College

Shaoyang, Hunan, 422000, China

RECRUITING

Related Links

• FDA Drug and Device Resources
• MedlinePlus related topics: HCC Stress

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Yu Yaqun, MD. PhD

CONTACT

+ 86 18172681387; yyq0129@glmc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: August 26, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)