Hepatoblastoma
Conditions
Interventions
Chemotherapy Group:ICE Chemotherapy Regimen
Sintilimab (PD-1 Inhibitor) Combined with Chemotherapy Group:Sintilimab
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be less than or equal to 18 years of age at the time of study enrollment; 2. Pathologically diagnosed as hepatoblastoma; 3. Enrolled patients must have undergone at least 4 cycles of conventional neoadjuvant therapy (excluding hepatic artery embolization chemotherapy TACE, hepatic arterial perfusion chemotherapy HAIC), including cisplatin monotherapy, C5V (cisplatin/carboplatin, 5-fluorouracil, vincristine), C5VD (cisplatin/carboplatin, 5-fluorouracil, vincristine, doxorubicin/epirubicin), C-CD (cisplatin/carboplatin, doxorubicin/epirubicin), SIOPEL-4 (cisplatin/carboplatin, doxorubicin/ Extrahepatic lesions that do not meet the criteria for R0 surgical resection after systemic chemotherapy and hepatic artery embolization (TAE) include any of the following: (1) POST-TEXT PHASE IV; (2) The tumor lesion involves three main branches of the hepatic vein (left hepatic vein, middle hepatic vein, right hepatic vein) or inferior vena cava; (3) The tumor lesion involves two main branches of the portal vein (the left branch of the portal vein and the right branch of the portal vein) or the main trunk of the portal vein; (4) The remaining liver volume after surgery was less than 20% of the standard liver volume calculated by three-dimensional imaging EDDA of the liver; 4. General characteristics: Lansky functional status score >=50 for patients aged =50 for patients aged > 10 years, life expectancy > 8 weeks, hemoglobin >8g/dL; Absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, total bilirubin < = 5 times the upper limit of normal (ULN) for this age group, aspartate aminotransferase (AST) or alanine transfection Ammonia (ALT) <10ULN. Serum creatinine < = 3 times normal metabolic parameters (i.e., blood electrolytes, glucose, calcium, and phosphatate), hepatitis B HBV-DNA <10^5IU/mL; 5. Not pregnant or breastfeeding; 6. No serious uncontrolled infection or enterocolitis; 7. Recovery from toxicity from prior therapy (CTCAE<=Grade 2).
Exclusion criteria
Exclusion criteria: 1. Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study; 2. Esophageal and gastric vein bleeding in the past 3 months; 3. There is significant ascites; 4. Radiotherapy or radiofrequency therapy within the past 3 months; 5. Have severe cardiovascular disease, such as New York Heart Association (NYHA criteria) heart failure above grade 2, unstable angina, unstable arrhythmia, or LVEF (left ventricular ejection fraction) on color cardiac imaging <50%; 6. Previous hypersensitivity reaction to monoclonal antibodies; 7. Patient has known, active, or suspected autoimmune disease. Enrollment is allowed in the following conditions: skin diseases not requiring systemic therapy (e.g. vitiligo, psoriasis), type I diabetes mellitus, autoimmune hypothyroidism on hormone replacement therapy; 8. Other active malignant tumors within 3 years prior to the first dose of study drug. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., can be enrolled; 9. Active viral hepatitis (e.g., hepatitis B, hepatitis C, unless antiviral therapy and HBV or HCV viral load below the minimum test line can be considered for enrollment), HIV positive, or known history of acquired immunodeficiency syndrome; 10. Severe infection before the screening period, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; 11. Active pulmonary tuberculosis within the past 1 year, with or without treatment; 12. Use of live attenuated vaccine within 30 days prior to screening; 13. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; 14. Previous treatment with any other investigational drug within 28 days prior to signing the ICF; 15. Dysphagia or known drug absorption disorder; 16. Pregnant or lactating; 17. Other situations that the investigator considers unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Incidence and grading of adverse events (AE) and serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Conversion and removal rate;Time to Progression, TTP;Overall Survival, OS;Disease Control Rate, DCR;Progression-Free Survival, PFS;Duration of Response, DOR;AFP-R; | — |
Countries
China
Contacts
Public ContactXia Qiang
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed