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

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: A Multicenter, Prospective, Observational Clinical Study

We will see if baseline emotional status (depressive versus non‑depressive) changes treatment outcomes in adults with BCLC stage B/C hepatocellular carcinoma getting hepatic arterial infusion chemotherapy combined with targeted therapy and immunotherapy.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07436845 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with clinically or pathologically confirmed BCLC stage B or C HCC, ECOG 0–1, Child‑Pugh score ≤7, no prior systemic therapy, at least one measurable intrahepatic lesion, and who are planned for HAIC combined with targeted therapy and immunotherapy are eligible.

Not a fit: Patients with prior systemic antitumor therapy, poor liver function (Child‑Pugh >7), ECOG ≥2, no measurable intrahepatic lesion, or those not receiving HAIC plus targeted and immunotherapy are unlikely to meet the study criteria or benefit from its findings.

Why it matters

Potential benefit: If emotional status is linked to outcomes, addressing depression or anxiety could become a modifiable way to improve progression‑free survival and overall treatment response.

How similar studies have performed: Prior studies have associated emotional distress with worse cancer outcomes generally, but applying these measures specifically to HAIC combined with targeted agents and immunotherapy in advanced HCC is novel and not well established.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Yuan Guosheng

Conditions Hepatocellular Carcinoma; Emotional Distress; HAIC; Immunotherapy; Targeted Therapy