Combining Sintilimab and Bevacizumab for Liver Cancer Patients with Blood Vessel Invasion

Perioperative Sintilimab Plus Bevacizumab Biosimilar and Transarterial Embolization, Hepatic Artery Infusion Chemotherapy (TACE-HAIC) for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus (PVTT): A Phase-2 Clinical Trial

This study is testing a new treatment combining two medications for people with advanced liver cancer and blood vessel invasion to see if it can help them live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: immunotherapy, Sintilimab, bevacizumab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06031285 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial investigates the effectiveness of perioperative treatment using Sintilimab, a PD-1 antibody, combined with a bevacizumab biosimilar and transarterial chemoembolization with hepatic arterial infusion chemotherapy (TACE-HAIC) for patients suffering from hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT). The study aims to determine if this combination can improve survival rates in patients who are not candidates for surgical resection. Eligible participants must have advanced HCC with specific criteria regarding tumor size and liver function. The trial is designed to provide insights into a potentially novel treatment approach for a challenging condition.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced hepatocellular carcinoma who have not received prior targeted therapy or immunotherapy and meet specific clinical criteria.

Not a fit: Patients with unresectable HCC who do not meet the eligibility criteria or have received prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival outcomes for patients with advanced liver cancer and portal vein invasion.

How similar studies have performed: While this approach is innovative, similar studies exploring combinations of immunotherapy and targeted treatments in liver cancer have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST requirements);
* Child-Pugh score ≤ 6 points (Child-Pugh A);
* BCLC staging is stage C; PVTT classification is combined with PVTT (VP1-2), and a single lesion in the liver (or multiple lesions with diameter) ≤ 10cm of primary liver cancer.
* Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
* ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria);
* Expected survival period ≥ 12 weeks;
* The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration):

Exclusion Criteria:

* The patient has any active autoimmune disease or a history of autoimmune disease;
* The patient is using systemic therapy or local treatment for HCC before enrollment;
* Severe allergic reaction to other monoclonal antibodies;
* Those with a known history of central nervous system metastasis or hepatic encephalopathy;
* Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past;
* Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except those who have only a small amount of ascites on imaging but not accompanied by clinical symptoms;
* Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
* Uncontrolled cardiac clinical symptoms or diseases, such as: NYHA level 2 or higher heart failure, unstable angina pectoris, myocardial infarction occurred within 1 year, clinically significant supraventricular or ventricular arrhythmia requires treatment or intervention , QTc\>450ms (male); QTc\>470ms (female);
* Abnormal coagulation function (INR\>2.0, PT\>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow the preventive use of low-dose aspirin and low molecular heparin;
* Significant clinically bleeding symptoms or clear bleeding tendency occurred within 3 months before randomization, such as pertussis/hemoptysis 2.5ml or more, gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, hemorrhagic stomach Ulcer or vasculitis, etc., if the stool occult blood is positive at the baseline, it can be re-examined. If it is still positive after the re-examination, a gastroscopy is required. If the gastroscope shows severe esophageal and gastric varices, it cannot be included in the group (3 before the group) Except those who have undergone gastroscopy within a month or less to exclude such cases);
* Arterial/venous thrombosis events that occurred within 6 months before randomization, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
* Known genetic or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.); Urine routine test showed urine protein ≥ ++ and confirmed 24-hour urine protein content\> 1.0 g;

The patient suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); Patients with bone metastases who received palliative radiotherapy within 4 weeks before participating in the study \>5% of the bone marrow area; The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or has previously received targeted therapy; Live vaccine may be vaccinated less than 4 weeks before study medication or may be administered during the study period; According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Conditions Hepatocellular Carcinoma