Combining Bevacizumab and Sintilimab for Intermediate Stage Liver Cancer Treatment
Bevacizumab in Combination With Sintilimab Versus Transcatheter Arterial Chemoembolization for the Treatment of Intermediate Stage Hepatocellular Carcinoma (Beyond Up-To-Seven Criteria), A Prospective, Randomized, Controlled Clinical Trial
This study is testing if combining two medications, bevacizumab and sintilimab, can help people with intermediate-stage liver cancer feel better compared to the usual treatment they would receive.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, sintilimab, bevacizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06090656 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining bevacizumab with sintilimab compared to the standard treatment of transcatheter arterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) who exceed the Up-To-Seven criteria. The study aims to determine if this combination therapy can provide better outcomes for patients who are not suitable for radical surgery or local treatment. Participants must have histologically confirmed HCC and meet specific eligibility criteria regarding tumor characteristics and liver function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed intermediate-stage hepatocellular carcinoma who meet specific tumor criteria.
Not a fit: Patients with early-stage HCC or those who have already received systemic antitumor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective option for patients with intermediate-stage HCC, potentially improving survival rates.
How similar studies have performed: Previous studies have shown promising results with similar combination therapies in treating unresectable hepatocellular carcinoma, but this specific approach for BCLC stage B has not been tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Histologically confirmed hepatocellular carcinoma, or meet the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for hepatocellular carcinoma. Age ≥ 18 years old. ECOG score 0. No systemic systemic antitumor therapy against hepatocellular carcinoma and transhepatic arterial intervention prior to treatment. Tumour extent: Barcelona Clinic Liver Cancer (BCLC) stage B unsuitable for radical surgery and/or local treatment, together with a tumour load exceeding the Up-To-Seven criteria, i.e. the sum of the size (in centimetres) of the largest tumour in the liver and the number of tumours greater than 7; tumor was bilobed with multiple lesions; at least one measurable lesion with CT/MRI showing arterial phase enhancement; no portal vein thrombus; and no extrahepatic metastasis. No risk of variceal bleeding: CT/MRI/esophagogastroduodenoscopy within 6 months did not suggest esophagogastric fundic varices and active ulcers. Child-Push A Normal hematologic function (platelets \>75×10E9/L; leukocytes \>3.0×10E9/L; neutrophils \>1.5×10E9/L) Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminases ≤ 3 times the ULN No ascites, normal coagulation function, albumin ≥ 30g/L Serum creatinine less than 1.5 times the upper limit of normal (ULN) Life expectancy \> 3 months Exclusion Criteria: Previously confirmed fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and bile duct carcinoma. history of hepatic encephalopathy or a history of liver transplantation. pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage. Acute or chronic active hepatitis B or C infection with hepatitis B virus (HBV) DNA \> 2000 IU/ml or 10E4 copies/ml; hepatitis C virus (HCV) RNA \> 10E3 copies/ml; positive for both hepatitis B surface antigen (HbsAg) and anti-HCV antibodies. Those who were below the above criteria after antiviral therapy could be enrolled. had any of the following within the 12 months prior to study entry: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; ongoing: arrhythmia ≥ grade 2 according to NCI-CTCAE criteria, prolonged QTc interval (\>450 ms in men , women \>470 ms); Uncontrollable hypertension, systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy. Renal failure requiring hemodialysis or peritoneal dialysis; Severe dysfunction of other vital organs; History of malignancy other than hepatocellular carcinoma within 3 years prior to screening, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, limited prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; evidence of brain or soft meningeal lesions; hemophilia or bleeding tendencies, who are taking therapeutic doses of anticoagulant therapy such as coumarin derivative drugs; pregnant or lactating females, all female patients of childbearing potential must have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result; Prior organ transplant history; Known HIV infection; Active Tuberculosis chemotherapy drug allergy; comorbid systemic or other serious co-morbidities that, in the judgment of the investigator, would make the patient unsuitable for participation in this study or substantially interfere with the appropriate assessment of the safety and toxicity of the prescribed protocol. Active or history of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, dry syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with other serious acute, chronic physical or psychiatric illnesses or abnormal laboratory tests that may increase the risk associated with study participation or that may interfere with the interpretation of study results or that the investigator deems unsuitable for enrollment. Patients with any history of significant noncompliance with medical regimens or inability to obtain reliable informed consent.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Wei He
- Email: hewei@sysucc.org.cn
- Phone: 15521248313
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.