NCT05617430
Recruiting
Phase 2
An Exploratory Study to Evaluate the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine With Sintilimab and Bevacizumab for BCLC-C Hepatocellular Carcinoma
Wuhan Union Hospital, China1 site in 1 country43 target enrollmentStarted: November 2, 2022Last updated:
ConditionsHepatocellular Carcinoma
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Wuhan Union Hospital, China
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Progression free survival (PFS) per RECIST v1.1
Overview
Brief Summary
This is a single-arm, exploratory study to evaluate the efficacy and safety of HAIC in combination with sintilimab and bevacizumab in the first line treatment of patients with BCLC-C hepatocellular carcinoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent should be signed before implementing any trial-related procedures
- •ECOG PS scores 0-1
- •Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by American Association for the Study of Liver Diseases (AASLD)
- •Barcelona Clinic Liver Cancer (BCLC) stage C
- •Newly diagnosed HHC patients without any previous treatment for the tumor
- •Child Pugh score of ≤
- •Estimated survival \> 12 weeks
- •At least one measurable lesion according to RECIST V1.1
- •Sufficient organ and bone marrow functions, with the laboratory test values within 7 days before the enrollment meeting the following requirements (no blood components, cell growth factors, albumin, and other drugs via intravenous or subcutaneous administrations are allowed for correction treatment within the first 14 days after the laboratory test results are obtained). The specific information is as follows:
- •Routine blood test: absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 75 × 109/L; hemoglobin (HGB) ≥ 9.0 g/dL.
Exclusion Criteria
- •Histologically/cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma.
- •History of hepatic encephalopathy or liver transplantation.
- •Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.
- •Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA \> 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA \> 103 copies/mL; hepatitis B surface antigen (HbsAg) and anti HCV antibody positive concurrently.
- •Presence of metastasis to the central nervous system.
- •Presence of bleeding events from esophageal or gastric varices caused by portal hypertension within the past 6 months. Presence of known severe (G3) varicose veins in endoscopy within 3 months before the first dose. Evidence of portal hypertension (including the finding of splenomegaly in imaging studies) with a high risk of bleeding assessed by the investigator.
- •Presence of any life-threatening bleeding events within the past 3 months, including the need for transfusion, surgery or local treatment, and continuous medication therapy.
- •Any arterial/venous thromboembolic events within 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis, or any other history of serious thromboembolism. Presence of implantable venous port or catheter derived thrombosis, or superficial venous thrombosis, barring stable thrombosis following the conventional anticoagulation treatment. Prophylactic use of low dose low molecular weight heparin (e.g., enoxaparin 40 mg/day) is permitted.
- •Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently. Presence of tumor thrombus of inferior vena cava.
- •A 10-day consecutive dosing of aspirin (\> 325 mg/day) or other drugs, e.g., dipyridamole and clopidogrel, known to inhibit the platelet function within 2 weeks before the first dose.
Arms & Interventions
HAIC + Sintilimab + Bevacizumab
Experimental
HAIC combine with Sintilimab and bevacizumab biosimilar
Intervention: HAIC (Drug)
HAIC + Sintilimab + Bevacizumab
Experimental
HAIC combine with Sintilimab and bevacizumab biosimilar
Intervention: Sintilimab (Drug)
HAIC + Sintilimab + Bevacizumab
Experimental
HAIC combine with Sintilimab and bevacizumab biosimilar
Intervention: Bevacizumab Biosimilar IBI305 (Drug)
Outcomes
Primary Outcomes
Progression free survival (PFS) per RECIST v1.1
Time Frame: From baseline to primary completion date, about 18 months
Defined as a duration from the date of initial treatment to disease progression or death of any cause
Secondary Outcomes
- The treatment-related adverse events (TRAEs)(From baseline to primary completion date, about 18 months)
- Duration of response (DoR) per RECIST v1.1 and mRECIST(From baseline to primary completion date, about 18 months)
- Overall survival (OS)(From baseline to primary completion date, about 18 months)
- Disease control rate (DCR) per RECIST v1.1 and mRECIST(From baseline to primary completion date, about 18 months)
- Overall response rate (ORR) per RECIST v1.1 and mRECIST(From baseline to primary completion date, about 18 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 2
HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT06244225Wuhan Union Hospital, China38
Recruiting
Phase 3
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCCHepatocellular CarcinomaChemotherapy EffectChemotherapeutic ToxicityNCT06041477Sun Yat-sen University540
Active, not recruiting
Phase 2
HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic CholangiocarcinomaIntrahepatic CholangiocarcinomaNCT06239532Qilu Hospital of Shandong University28
Completed
Not Applicable
Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV InfectionHPV InfectionNCT06752083Liaquat University of Medical & Health Sciences289
Recruiting
Phase 2
HAIC Combined With Sintilimab and Bevacizumab Biosimilar for Unresectable HCCHepatocellular CarcinomaNCT05029973Tianjin Medical University Cancer Institute and Hospital30