Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma(HCC)

This is an interventional treatment trial for Metastatic Hepatocellular Carcinoma focused on measuring Phase Ib/II, HCC, Metastatic Hepatocellular Carcinoma Read More

Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial;
2. Age ≥20 years male and female;

3. Subjects must have confirmed diagnosis of unresectable HCC with any of following criteria:

   i. Histologically or cytologically confirmed diagnosis of HCC ii. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy;

4. Have documented disease progression or intolerance after first-line systemic treatment;
5. At least one measurable lesion based on RECIST version 1.1 ;
6. Child-Pugh score ≤ 6 (Child-Pugh A)score within 7 days of first dose of study drug;
7. ECOG performance status: 0-1;
8. Have a predicted life expectancy of greater than 3 months;

9. The functions of the important organs are confirmed with the following requirement:

   • Hemoglobin (HGB) ≥ 90 g/L;
   • White blood cell count (WBC) ≥ 3×10^9/L；
   • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L；
   • Platelets (PLT) ≥ 100×10^9/L；
   • Total bilirubin (TBIL) ≤ 1.5× Upper limit of normal value (ULN)
   • Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) ≤ 5× ULN
   • Creatinine (Cr) ≤ 1.5×ULN；
   • International normalization ratio (INR)or prothrombin time (PT) ≤ 1.5×ULN ;
10. Women must have a negative serum or urine pregnancy test within 72 hours prior to the start of investigational product;
11. Women of childbearing potential must agree to contraception for the duration of study treatment and 5 months after the last dose of study treatment;
12. Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

1. Imaging findings for HCC corresponding to any of the following:

   • HCC with ≥ 50% liver occupation
   • Clear invasion into the bile duct
   • Portal vein invasion or thrombosis at the main portal branch (Vp4)
2. Gastric or esophageal varices that require treatment;
3. If prior history of DVT/PE, the patient needs to be on stable doses of anticoagulation with low molecular weight heparin or oral anticoagulant for at least two weeks;
4. Esophageal vein dilation, grade A of active peptic ulcer rating, and all bleeding risk by gastroscopy;
5. History of arterial thromboembolic event in past 6 months;
6. Active bleeding disorder, including gastrointestinal bleeding event or active hemoptysis within 28 days prior to study treatment;
7. Have central nervous system (CNS) metastases;
8. Has a known history of human immunodeficiency virus (HIV);
9. Has received prior immune checkpoint inhibitor (including those targeting PD-1, PD-L1 or PD-L2, CD137, or cytotoxic T-lymphocyte antigen [CTLA-4]);
10. Has a known history of, or any evidence of, interstitial lung disease or active non- infectious pneumonitis;
11. Has active autoimmune disease that has required systemic treatment in past 2 years;
12. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
13. Any history of drug or alcohol dependency or abuse within the prior 1 years;
14. Has known active Hepatitis B or Hepatitis C within 2 weeks prior to initiation of study treatment Note: Patients with HBV infection are required to be receiving effective antiviral therapy over two weeks, and then have continuous therapy in study period;
15. Pregnant, breast feeding, or planning to become pregnant;
16. Have a history of severe hypersensitivity reaction to monoclonal antibody;
17. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug;
18. Have surgery, radiotherapy, ablation within one month before screening;
19. Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial