Combination treatment for advanced liver cancer
Hepatic Arterial Infusion or Intravenous Infusion of Adebrelimab, Combined With Bevacizumab and Hepatic Arterial Infusion of FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma: a Multicenter, Open Label, Randomized Phase II Trial
This study is testing a new combination of treatments for people with advanced liver cancer to see if it can help them respond better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, Adabrelimab, Bevacizumab, adebrelimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06737913 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of Adabrelimab, administered either through hepatic arterial infusion or intravenously, combined with FOLFOX chemotherapy and Bevacizumab for patients with advanced unresectable hepatocellular carcinoma (HCC). Participants will be randomized into two groups to receive either hepatic arterial infusion of Adabrelimab or intravenous administration, alongside standard chemotherapy and Bevacizumab. The goal is to improve response rates and overall prognosis for patients suffering from this aggressive form of liver cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with advanced stage hepatocellular carcinoma who have not received prior systemic therapy.
Not a fit: Patients with autoimmune diseases or those with a poor prognosis (expected survival time less than 3 months) may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve response rates and survival outcomes for patients with advanced hepatocellular carcinoma.
How similar studies have performed: Previous studies have shown promising results with similar combinations of therapies for advanced HCC, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Voluntarily participate in the study and sign the informed consent form;
2. Aged ≥18 years (calculated as of the date of signing the informed consent form);
3. Diagnosed with hepatocellular carcinoma (HCC) by clinical or pathological means;
4. Barcelona Clinic Liver Cancer (BCLC) stage C, with vascular/bile duct invasion or distant metastasis (excluding cases with Vp4-type tumor thrombus);
5. No prior systemic therapy for HCC; or progression or residual lesions following prior local therapy for HCC (including but not limited to surgery, ablation, radiotherapy, or transarterial chemoembolization \[TACE\]), with an interval of at least one month between the last local treatment and enrollment;
6. ECOG Performance Status (PS) score of 0-1 and Child-Pugh grade A or grade B with a score of 7;
7. No history of autoimmune disease;
8. An expected survival time of ≥3 months;
9. At least one measurable lesion (per RECIST v1.1 criteria, the longest diameter of the measurable lesion on spiral CT scan must be ≥10 mm or the short axis of enlarged lymph nodes must be ≥15 mm; lesions previously treated locally can be considered target lesions if progression is confirmed per RECIST v1.1 criteria);
10. Sufficient hematologic, hepatic, and renal function, with laboratory tests within the following parameters performed within one week prior to enrollment:
* Neutrophil count ≥1.5×10\^9/L;
* Platelet count ≥75×10\^9/L;
* Hemoglobin ≥90 g/L;
* Serum ALT and AST ≤5×upper limit of normal (ULN); ⑤ Serum creatinine ≤1.5×ULN; ⑥ International Normalized Ratio (INR) \<2.3, or prothrombin time ≤ULN+6 seconds; ⑦ Albumin ≥30 g/L;
* Total bilirubin ≤3×ULN.
11. Women of childbearing potential must have a negative serum or urine pregnancy test within seven days prior to study enrollment, must not be breastfeeding, and must agree to use contraceptive measures during the study and for six months after its conclusion; men must agree to use contraceptive measures during the study and for six months after its conclusion.
Exclusion Criteria:
1. Patients with a severe allergy to iodine contrast agents who are unable to undergo hepatic arterial infusion chemotherapy (HAIC);
2. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within one month prior to randomization;
3. Active infections that cannot be effectively controlled;
4. Severe gastroesophageal varices; untreated or incompletely treated gastroesophageal varices (with bleeding or high risk of bleeding);
5. Presence of brain metastases or bone metastases requiring urgent surgical or radiotherapy intervention;
6. Pregnant or suspected to be pregnant, or currently breastfeeding;
7. Current use or recent use (within 10 days before the initiation of the study treatment) of aspirin (\>325 mg/day, maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
8. Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, or cerebral infarction) or pulmonary embolism, occurring within six months prior to the initiation of the study treatment;
9. Congenital or acquired immunodeficiency;
10. History of other malignant tumors;
11. Any of the following conditions within 12 months prior to the initiation of the study: myocardial infarction, severe/unstable angina, or congestive heart failure;
12. Renal insufficiency requiring dialysis;
13. History of organ transplantation;
14. Severe acute or chronic physical or mental illnesses or laboratory abnormalities that may increase study risks or interfere with result interpretation, rendering the patient unsuitable for enrollment.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lujun Shen, M.D.
- Email: shenlj@sysucc.org.cn
- Phone: 86-13560365452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.