Impact of Emotional Stress on Immune Checkpoint Inhibitor Treatment Outcomes in Hepatocellular Carcinoma: A Multicohort Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 5
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
详细描述
This multi-center prospective cohort study investigates the relationship between emotional distress (ED) and treatment outcomes in patients receiving immune checkpoint inhibitor (ICI) therapy for hepatocellular carcinoma (liver cancer). Recent research suggests that emotional distress may influence how well cancer treatments work, particularly immunotherapy, but this connection hasn't been well studied in liver cancer patients.
Scientific Background: Liver cancer is a major global health concern, with increasing cases worldwide. While immunotherapy has emerged as a promising treatment option, not all patients respond equally well to this therapy. Understanding factors that might influence treatment success is crucial for improving patient care. Recent studies have shown that emotional distress can affect immune system function, which may impact how well immunotherapy works.
Study Design: The study includes three distinct cohorts of liver cancer patients:
Cohort 1: Patients with unresectable liver cancer starting first-line ICI therapy Cohort 2: Patients receiving ICI therapy after surgery (adjuvant therapy) Cohort 3: Patients receiving ICI therapy before surgery (neoadjuvant therapy)
Comprehensive Assessment Approach:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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):
- •Inclusion Criteria:
- •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
- •Pathological stage II or III (AJCC 8th edition)
- •Will start adjuvant ICI therapy within 4-6 weeks after surgery
- •Expected survival > 12 months
- •Exclusion Criteria:
- •Currently taking antidepressant or anti-anxiety medications
- •Previous diagnosis of psychiatric disorders
- •Concurrent malignancy
- •Unable to complete psychological assessments
- •Residual lesions after surgery
- •Child-Pugh score B or C
- •Cohort 3 (SOLACE-3):
- •Inclusion Criteria:
- •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 resectable HCC by pathology or imaging
- •Has at least one measurable lesion (RECIST 1.1)
- •About to receive neoadjuvant ICI treatment
- •Expected survival > 12 months
- •Exclusion Criteria:
- •Currently taking antidepressant or anti-anxiety medications
- •Previous diagnosis of psychiatric disorders
- •Severe cardiac, pulmonary, or renal dysfunction
- •Concurrent malignancy
- •Unable to complete psychological assessments
- •Previous systemic anti-tumor therapy
- •Symptomatic brain metastases
- •Child-Pugh score B or C
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 24 months
Time from treatment initiation to disease progression or death
Disease-Free Survival (DFS)
时间窗: Up to 36 months
Time from surgery to disease recurrence or death
Pathological Complete Response (pCR) Rate
时间窗: At time of surgery (approximately 6-8 weeks after neoadjuvant therapy)
Percentage of participants achieving complete pathological response
次要结局
- 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).)
- Changes in Depression Scores (PHQ-9)(Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years))
- Changes in Anxiety Scores (GAD-7)(Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years))
- Changes in Depression Scores (HAMD)(Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years))
- Changes in Anxiety Scores (HAMA)(Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years))
研究者
Yu Yaqun
Principal Investigator,
Guilin Medical University, China