Hepatocellular carcinoma
Conditions
Interventions
Case series:Sintilimab combined with IBI305 and mFOLFOX4
Sponsors
The Third Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the study and voluntarily sign the informed consent form (ICF), and be able to comply with the program's visits and related procedures; 2. Advanced and/or metastatic primary hepatocellular carcinoma confirmed by histology and/or cytology; or patients with cirrhosis who meet the clinical diagnostic criteria of the American Society for the Study of Liver Diseases (AASLD) on hepatocellular carcinoma; 3. Have not received systemic anti-tumor therapy for hepatocellular carcinoma before the first administration. Recurrence and metastasis was confirmed 6 months after the adjuvant or neoadjuvant therapy (including but not limited to chemotherapy or combined chemoradiotherapy); After discussion by the multidisciplinary expert team of HCC, patients who cannot be cured radically again can be included in this study. The clinical stage of Barcelona Clinic Liver Cancer stage C. Phase B not suitable for radical surgery and/or local treatment; 4. At least one measurable lesion, or a measurable lesion that has clearly progressed after local treatment, according to the standard 1.1 evaluation of solid tumor efficacy (RECIST V1.1); 5. Child-Pugh score = 3 months; 10. Laboratory examination within 7 days before enrollment must meet the following standards: (1) Blood routine: neutrophil >= 1.5 x 10^9 / L; platelets >= 75 x 10^9 / L; hemoglobin >= 90g / L (no concentrated red blood cells transfusion within 2 weeks); (2) Renal function: serum creatinine (Cr) = 50mL / min (Cockcroft-Gault formula); Urine routine results show urine protein = 2 + should take a 24-hour urine collection and the 24-hour urinary protein quantification = 28g / L; Alanine aminotransferase (ALT) <= 5 ULN; (4) Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 ULN; 11. Female patients of childbearing age or male patients whose sexual partners are females of childbearing age need to take effective contraception during the entire treatment period and 6 months after the last medication. Within 21 days of enrollment, women of childbearing age must confirm a negative serum pregnancy test and agree to use effective contraception during study drug use and within 28 days after the last dose; Women of childbearing age are defined as sexually mature women in this program: 1) not undergoing hysterectomy or bilateral ovariectomy; 2) natural menopause has not continued for 24 consecutive months (amenorrhea after cancer treatment does not exclude fertility) Menstruation has occurred at any time within the previous 24 consecutive months).
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions are excluded to join this clinical study: 1. Have received anti-tumor cytotoxic drug treatment, biological drug treatment (such as monoclonal antibody), or other research drug treatment within 4 weeks before enrollment. Have received tyrosine kinase inhibitor treatment, Chinese medicine with anti-tumor indications, and medicines with immunomodulatory effects (including thymosin, interferon, and interleukin, except for local use for controlling pleural or ascites) within 2 weeks before enrollment. 2. Received local treatment for liver cancer within 4 weeks before the first dose; received radiation therapy within 4 weeks before the first dose; For patients who received radiation therapy 4 weeks before the first dose, all the conditions below should be required before joining the group: there are currently no radiation-related toxic reactions, no need to take glucocorticoids, exclude radiation pneumonia, radiation hepatitis, radiation enteritis, etc. Received radiopharmaceutical treatment within 8 weeks before enrollment, with the exception of local palliative radiotherapy for bone metastases. 3. Have undergone major surgery within 4 weeks before enrollment or have not fully recovered from the previous surgery (for the definition of major surgery, refer to the level 3 stipulated in the "Administrative Measures for the Clinical Application of Medical Technology" implemented on May 1, 2009 And level 4 surgery). 4. Patients with clinical symptoms of central nervous system metastases (such as brain edema, requiring glucocorticoid intervention, or the progression of brain metastases) and/or cancerous meningitis. Patients who have previously received therapies to control brain or meningeal metastasis, disease was under control and stable for at least 2 months, and have stopped systemic glucocorticoid therapy (dose>10mg/day of prednisone) for more than 4 weeks can be included . 5. Patients with acute or chronic active hepatitis B or C infection, with hepatitis B virus (HBV) DNA> 2000 IU/ml or 10^4 copies / ml; hepatitis C virus (HCV) RNA> 10^3 copies / ml; 6. Other malignancies diagnosed within 5 years prior to the first dose of tested drugs, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and / or carcinoma in situ after radical resection. If other malignant tumors or liver cancers are diagnosed more than 5 years before inclusion of this trial, a pathological or cytological diagnosis of the recurrent metastatic lesions is required. 7. Active autoimmune disease or history of autoimmune disease (including, but not limited to, interstitial Pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, decreased thyroid function; subjects with vitiligo or childhood asthma that has completely resolved, without any intervention as adults) Active autoimmune disease that requires systemic treatment (such as glucocorticoids or immunosuppressants) within 2 years before the first dose. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are allowed. Known history of primary immunodeficiency. Patients with only autoimmune antibodies positive are required to confirm the existence of autoimmune disease according to the investigator's judgment. 8. Have received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any oth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;Tumor objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Duration of remission;Disease control rate;6-month progression-free survival;1 year survival rate;2 year survival rate; | — |
Countries
China
Contacts
Public ContactXiangyuan Wu
Third Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed