Emotional health and outcomes for advanced liver cancer patients receiving HAIC plus targeted therapy and immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective observational study will enroll 90 adults with BCLC stage B/C hepatocellular carcinoma who are planned for hepatic arterial infusion chemotherapy combined with targeted therapy and immunotherapy. Participants will be divided into depressive and non‑depressive groups based on PHQ‑9/GAD‑7 scores (≥5) and followed over time with progression‑free survival as the primary endpoint and objective response rate, disease control rate, overall survival, and safety as secondary endpoints. Emotional status, quality of life (EORTC QLQ‑C30), and peripheral neuroendocrine‑immune markers will be measured at predefined time points to examine dynamic associations with clinical outcomes. The study is observational and does not alter the cancer treatments prescribed by clinicians.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

  2: Aged 18 years or older, both male and female.

  3: Patients with clinically or pathologically confirmed Barcelona Clinic Liver Cancer (BCLC) stage B or C hepatocellular carcinoma, who are deemed eligible for hepatic arterial infusion chemotherapy (HAIC) combined with targeted and immunotherapy as assessed by the clinician.

  4: No prior systemic antitumor therapy.

  5: At least one intrahepatic evaluable lesion is present, with the intrahepatic lesion constituting the primary tumor burden. (According to RECIST v1.1 criteria, the measurable lesion must have a long diameter \>= 10 mm on spiral CT scan, or enlarged lymph nodes must have a short diameter \>= 15 mm.);

  6: Child-Pugh score \<= 7 (Rated as Child-Pugh class A or B);

  7: Able to swallow tablets normally;

  8: ECOG performance status: 0-1;

  9: Patients' psychological status and laboratory test indicators can be comprehensively documented at baseline and during the treatment period;

  10: All patients have no history of other psychiatric disorders.

Exclusion Criteria:

1\. Presence of any active autoimmune disease or history of autoimmune diseases (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; childhood asthma that has completely resolved in adulthood and requires no intervention may be included; asthma requiring medical intervention with bronchodilators is excluded).

2: Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (at a dose \>10mg/day of prednisone or equivalent), continuing within 2 weeks prior to enrollment.

3: Known history of central nervous system metastases or hepatic encephalopathy.

4: Congenital or acquired immunodeficiency (e.g., HIV infection);

5: History or presence of other malignancies within the past 3 years (with the exception of cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).

6: Current use of antidepressant or anti-anxiety medications, or severe psychiatric disorders requiring other psychotropic medications.

7: Any other condition deemed by the investigator as likely to affect the study results or lead to premature termination of the study, such as alcohol or drug abuse, other severe co-morbidities (including psychiatric disorders) requiring concomitant treatment, or severe laboratory abnormalities.

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Where it's running

• Nanfang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yuan Guosheng
• Email: guoshengyuan1991@163.com
• Phone: 86-020-13268121075

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.