Hepatocellular carcinoma
Conditions
Interventions
Anlotinib combined with bemrelizumab and HAIC as first-line treatment:Dosage and Administration: Hepatic artery infusion chemotherapy (HAIC) was performed using the FOLFOX regimen: oxaliplatin 85 mg/m
HAIC treatment was limited to a maximum of 6 cycles. Anlotinib: 10 mg orally, days 1–14, every 3 weeks
Bevacizumab: 1200 mg intravenously over 60 minutes, day 1, every 3 weeks. The combined regimen constituted a treatment cycle every 3 weeks, with a maximum treatment duration of 2 years or until succes
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 80 years, both genders; 2. Unresectable hepatocellular carcinoma (HCC) meeting the China Liver Cancer Staging (CNLC) criteria and the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD); 3. At least one measurable lesion (definition of measurable lesion: non-lymph node lesion with longest diameter >=10 mm, or lymph node lesion with short diameter >=15 mm); patients with unresectable HCC; Child-Pugh liver function score =12 weeks; 6. No use of any anti-HCC drugs (including modern Chinese herbal preparations with HCC indications: Delisheng injection, Kanglaite injection or soft capsules, Aidi or Kangsaidi injection, elemene, Huaier granules, and Ganfule tablets) within 2 weeks before the first dose; 7. ECOG performance status 0-1; 8. For active hepatitis B, effective antiviral therapy (per local standard of care, e.g., entecavir or tenofovir) is required, with HBV DNA =90 g/L; 2) ANC >=1.5×10^9/L; 3) PLT >=75×10^9/L; (2) Biochemistry (without albumin use within 14 days): 1) ALB >=28 g/L; 2) ALT and AST <5.0×ULN; 3) TBIL <=4.0×ULN (for obstructive jaundice, may be performed after PTCD); 4) Creatinine <=1.5×ULN; 5) Electrolytes essentially normal or normalized after treatment; (3) Urinalysis: 1) Urine protein <=1+; 10. Patients voluntarily enroll and, after signing written informed consent, are able to undergo diagnosis, treatment, and follow-up as per protocol.
Exclusion criteria
Exclusion criteria: 1. The pathological diagnosis confirmed fibrous lamellar HCC, sarcomatoid HCC, or a mixed type of hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC); 2. Moderate or greater volume of pleural/ascitic fluid with clinical symptoms; 3. Obstructive jaundice and liver failure, accompanied by hepatic encephalopathy; 4. Patients with dual or multiple cancers: A history of previous malignant tumors other than hepatocellular carcinoma, cervical carcinoma in situ, and non-melanoma skin cancer, unless the previous malignant tumor was diagnosed and clinically cured at least 5 years ago with no evidence of subsequent recurrence; 5. Patients with active bleeding or coagulation disorders (prothrombin time PT > 16 seconds, activated partial thromboplastin time APTT > 43 seconds, international normalized ratio INR >= 2), those with a bleeding tendency, or those undergoing thrombolysis, anticoagulation, or antiplatelet therapy; 6. Concomitant use with medications that may prolong QTc interval and/or induce torsades de pointes (Tdp), or that may affect the metabolism of chemotherapeutic agents; 7. Pregnant or lactating women; men and women of childbearing age who are unwilling or unable to adopt effective contraceptive measures; 8. Any significant clinical or laboratory abnormalities deemed by the investigator to affect safety evaluation, such as: uncontrolled active infection (>NCI-CTCAE v5.0 criterion level 2), uncontrolled diabetes (>NCI-CTCAE v5.0 criterion level 2), hypertension refractory to treatment with two or more antihypertensive agents failing to achieve the target range (systolic blood pressure NCI-CTCAE v5.0 criterion level 2); 9. Patients with a history of brain or subdural metastases or severe psychiatric disorders; those suspected of central nervous system metastasis require cranial MRI for exclusion; 10. Patients with a history of gastrointestinal bleeding within the past three months or a confirmed predisposition to gastrointestinal bleeding are ineligible for enrollment. Examples include known locally active ulcerative lesions or fecal occult blood levels >=++; those with persistent fecal occult blood level + should undergo gastroscopy; 11. Patients with severe gastric/oesophageal wall varices requiring interventional therapy; 12. Abdominal or gastrointestinal perforation or peritoneal abscess occurred within 4 weeks prior to the first dose of medication; 13. Patients with significantly abnormal glomerular filtration rate (endogenous creatinine clearance 1.5×ULN); 14. Active hepatitis C, defined as individuals with anti-HCV positivity or HCV-RNA positivity accompanied by abnormal liver function; those with a known history of HIV infection; 15. Patients who have received other investigational drugs or investigational medical devices within 4 weeks prior to the first dose administration; or patients who have previously used drugs with antitumor indications, with less than 2 weeks or 5 drug half-lives (whichever is longer) remaining between treatment completion and the initiation of this study medication, and whose treatment-related adverse events have not resolved to <=CTCAE Grade 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) assessed by RECIST v1.1 criteria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) assessed by mRECIST criteria;Progression-Free Survival (PFS);Overall Survival (OS);Disease Control Rate (DCR);Duration of Response (DOR);Surgical Conversion Rate;Change in AFP and PIVKA-II levels; | — |
Countries
China
Contacts
Public ContactShang Changzhen
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed