Combination treatment for unresectable hepatocellular carcinoma

Phase II Study Evaluating the Efficacy of Tremelimumab (T) Plus Durvalumab (D) With Lenvatinib Combined With Concurrent Hepatic Arterial Infusion Chemotherapy (HAIC) in Patients (Pts) With Unresectable Hepatocellular Carcinoma (uHCC)

This study is testing a new combination of treatments for people with advanced liver cancer to see if it can help them live longer and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Hunan Provincial People's Hospital (Academic / other)
• Drugs / interventions: Tremelimumab, Durvalumab, Lenvatinib, immunotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06364007 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the efficacy and safety of a combination treatment involving hepatic arterial infusion chemotherapy (HAIC), immunotherapy with durvalumab and tremelimumab, and lenvatinib for patients with unresectable hepatocellular carcinoma (HCC). The study aims to improve overall survival by utilizing a regimen that has shown promise in previous studies. Eligible participants include those aged 18 to 70 with unresectable HCC who have not received systemic treatment or have progressed after prior treatment. The trial will assess the treatment's effectiveness based on specific criteria for tumor response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with unresectable or metastatic hepatocellular carcinoma and at least one assessable lesion.

Not a fit: Patients with resectable HCC or those who have received prior systemic treatment without progression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with unresectable hepatocellular carcinoma.

How similar studies have performed: Previous studies have shown promising results with similar combination therapies in hepatocellular carcinoma, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age 18 \~ 70 years old (including 70 years old), male and female;
2. Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;
3. Patients with unresectable or metastatic hepatocellular carcinoma;
4. No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;
5. Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;
6. At least one assessable lesion (mRECIST criteria);
7. Expected survival time ≥ 3 months;
8. ECOG 0 \~ 1;
9. Child Pugh ≤ 7;
10. Be able to cooperate to observe adverse events;
11. Major organs are functioning normally:

    * Hemoglobin ≥ 90 g / L;
    * ANC ≥ 1.5 × 109/L；
    * Platelet count ≥ 75 × 109/L；
    * Albumin ≥ 28 g / L;
    * Total bilirubin ≤ 2 × ULN;
    * AST, ALT ≤ 5 × ULN；
    * ALP ≤ 5 × ULN；
    * Creatinine ≤ 1.5 × ULN；
    * INR or PT ≤ 1.5 × ULN； J) APTT ≤ 1.5 × ULN。

Exclusion Criteria:

1. History of symptomatic congestive heart failure, unstable angina pectoris,
2. Uncontrolled cardia arrhythmia
3. History of hepatic encephalopathy
4. Uncontrolled arterial hypertension
5. Co-infection with HBV and HDV

Where this trial is running

Changsha, Hunan

• Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University) — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Chuang Peng, PhD

Conditions Hepatocellular Carcinoma; HAIC; uHCC; immunotherapy