Ruptured HCC
Conditions
Interventions
Experimental group:Sintilimab 200 mg by intravenous infusion on Day 1 of every 3-week cycle. Plus Bevacizumab 15 mg/kg by intravenous infusion on Day 1 of every 3-week
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. Aged 18-75 years, regardless of gender; 3. Preoperative or intraoperative imaging-confirmed spontaneous rupture hemorrhage, with postoperative pathological diagnosis of hepatocellular carcinoma; for intraoperative accidental discovery of ruptured hemorrhage due to liver cancer, a medical history must prove that abdominal pain occurred within two weeks before surgery; 4. CNLC stage I-II; 5. Underwent surgical resection, with intraoperative irrigation of more than 5000 ml of distilled water or saline, postoperative pathology indicates negative resection margins, and imaging confirms complete remission (CR) within 4–8 weeks after surgery; 6. ECOG PS score: 0–1; 7. Child-Pugh liver function grade: A (=12 months; 9. Laboratory test values within 3 days prior to initial medication must meet the following requirements: (1) Complete blood count: (except for hemoglobin, no blood transfusion, use of granulocyte colony-stimulating factor [G-CSF], or drugs to correct it within 2 weeks prior to screening): 1) Absolute neutrophil count >=1.5×10^9/L; 2) Platelets >=75×10^9/L; 3) Hemoglobin >=90 g/L; (2) Biochemical tests: 1) Serum albumin >=30 g/L; 2) Total serum bilirubin 50 mL/min; (3) International normalized ratio (INR) =2, a 24-hour urine protein quantification can be performed, with 24-hour urine protein <1.0g eligible for enrollment); 10. For patients infected with hepatitis B virus (HBV), such as those who are HBsAg positive, HBV-DNA must be tested, and HBV-DNA should be <2000 IU/mL (if the research center only has the unit copy/mL, it must be <10^4 copy/mL); subjects with HBV-DNA = 2000 IU/mL must receive at least 1 week of antiviral treatment before the first dose (only nucleoside drugs such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide are allowed), and the viral load must decrease by more than 10-fold (1 lg) compared with before the first dose. For HBV-infected patients, continuous antiviral treatment is required throughout the study. Subjects positive for hepatitis C virus (HCV)-RNA must receive antiviral treatment according to the treatment guidelines. 11. Women of childbearing potential must have a negative pregnancy test (ß-HCG) before the first dose. Women of childbearing potential and men (who have sexual relations with women of childbearing potential) must agree to use contraception during the treatment period and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis of non-hepatocellular carcinoma (such as cholangiocarcinoma, mixed liver cancer, etc.); 2. Intraoperative intraperitoneal chemotherapy drugs; 3. Child-Pugh score of grade B or C; 4. ECOG performance status score >1; 5. Postoperative imaging confirming extrahepatic metastasis, residual lesions, or recurrence; 6. Previous systemic anti-tumor treatment (including targeted therapy or immunotherapy), including systemic treatment (including investigational drugs) and local treatment, such as TACE (excluding preoperative TAE hemostatic treatment); as well as participants who received adjuvant TACE therapy after surgical resection; 7. Moderate to severe ascites with clinical symptoms requiring therapeutic paracentesis or drainage, or Child-Pugh ascites score >2 (excluding cases with only a small amount of ascites visible on imaging without clinical symptoms); uncontrolled or moderate to large pleural effusion or pericardial effusion; 8. Subjects who currently have interstitial pneumonia or interstitial lung disease, have a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or have other lung conditions that may interfere with the assessment and management of immune-related lung toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or evidence of active pneumonia on chest CT at screening, or those with severely impaired lung function. Subjects with a history of radiation-induced pneumonitis are allowed; active tuberculosis is excluded. 9. Subjects with active autoimmune disease or a history of autoimmune disease with potential for recurrence [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects can be enrolled if hypothyroidism is controlled with hormone replacement therapy)]; subjects with skin conditions not requiring systemic treatment such as vitiligo, psoriasis, alopecia; subjects with insulin-controlled type I diabetes or fully resolved childhood asthma not requiring any intervention as an adult can be enrolled; subjects with asthma requiring medical intervention with bronchodilators cannot be enrolled; 10. Use of immunosuppressants or systemic steroids for immunosuppression purposes within 2 weeks before drug administration (dose greater than 10 mg/day prednisone or equivalent); in the absence of active autoimmune disease, inhaled or topical corticosteroids as well as adrenal hormone replacement therapy at a dose of <=10 mg/day prednisone equivalent are allowed; 11. Subjects with a history of gastrointestinal bleeding or a clear predisposition to gastrointestinal bleeding within 6 months before drug administration, such as those at risk of bleeding or with severe esophageal or gastric varices, active local gastrointestinal ulcers, or persistent positive fecal occult blood tests cannot be enrolled (fecal occult blood positive at baseline can be retested; if positive again, endoscopy is required, and if endoscopy indicates esophageal or gastric varices with bleeding risk, the subject cannot be enrolled); baseline CT/MRI showing esophageal or gastric varices must be evaluated by the investigator; mild to moderate varices may be enrolled; subjects who had abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before rando
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactChen Yongjun
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed