| Eligibility |
"The patients meeting all the following inclusion criteria can be enrolled in this study:
1. Age of 18-70 years (inclusive), male or female.
2. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and
Treatment of Primary Liver Cancer (2017 Edition).
3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona
Clinic Liver Cancer staging system (BCLC stage). In case of stage B, the patient must
be unsuitable for surgery and/or local therapy, or have progressive disease after
surgery and/or local therapy, or refuse surgery and/or local therapy (special
instruction and signature required).
4. No previous use of any systemic therapy or HCC.
5. Having = 1 measurable lesion in accordance with RECISTv1.1.
6. Grade A Child-Pugh hepatic function, with no history of hepatic encephalopathy.
7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1.
8. Expected survival =12 weeks.
9. Adequate hematologic and end-organ function..
10. In case of HBsAg (+) and/or HBcAb (+), HBV DNA is required to be < 500 IU/mL, and it
is required to continue the effective anti-HBV therapy that has been adopted in the
full course, or start to use Entecavir or tenofovir in the full course during the
study. HBV/HCV co-infected patients will be excluded. Patients with a history of HCV
infection but with negative HCV RNA PCR results can be considered uninfected with HCV.
11. Female patients of childbearing potential must receive serum pregnancy test within 7
days before enrollment, have negative result, and agree to use reliable and effective
contraceptive methods during the trial and within 60 days after the last dose of study
drug. The male patients whose partners are women of childbearing potential must agree
to use reliable and effective contraceptive methods during the trial and within 60
days after the last dose of study drug.
12. Being voluntary to participate in the study, sufficiently informed consent and
signature of written informed consent form, with good compliance.
Patients can not be enrolled in the study if any one of the following criteria is
fulfilled:
1. Known cholangiocellular carcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid
hepatocellular carcinoma and hepatic fibrolamellar carcinoma.
2. Malignant tumor except HCC in the past 5 years: however, localized tumor cured in the
study is excluded, including cervical carcinoma in situ, skin basal cell carcinoma and
carcinoma in situ of prostate.
3. Hepatic surgery and/or local therapy or treatment with investigational product for HCC
within 4 weeks prior to enrollment; palliative therapy for bone metastatic lesion
within 2 weeks prior to enrollment. Toxicity reaction induced by previous therapy
(except alopecia) not recovered to = grade 1 (NCI-CTCAE v5.0). Chinese medicine
preparation with anti-liver cancer effect within 2 weeks prior to enrollment.
4. Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious
moderate peritoneal effusion at screening,
5. History of gastrointestinal hemorrhage within 6 months prior to enrollment; the
patients with portal hypertension need to receive gastroscopy to exclude the patients
with "red sign", if they are considered by investigators to have high risk for
hemorrhage . The patient needs to be excluded if there is a history of "red sign" in
gastroscopy.
6. Having = grade 3 (NCI-CTCAE v5.0) gastrointestinal or non-gastrointestinal fistula at
present.
7. Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer
thrombus in inferior vena cava should be excluded. However, the patients with cancer
thrombus in the main trunk of portal vein but unobstructed branch of contralateral
portal vein are allowed to be enrolled.
8. Previous history of serious cardiovascular and cerebrovascular diseases:
9. Having major bleeding and coagulation disorders or other obvious evidence on
hemorrhagic tendency:
10. Medium to large surgical treatment within 4 weeks prior to enrollment, however, not
including diagnostic biopsy.
11. Central nervous system metastasis.
12. Serious, uncured wound, active ulcer or untreated bone fracture.
13. Vaccination of live vaccine within 30 days prior to enrollment.
14. Active autoimmune diseases requiring systemic treatment (i.e., immunomodulatory drug,
corticosteroid or immunosuppressant) in the past 2 years; however, replacement therapy
(e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for
renal or pituitary insufficiency) will not be considered as systemic therapy and is
allowed to be used, and enrollment is allowed.
15. History of clear interstitial lung disease or non-infectious pneumonia, unless induced
by local radiotherapy; history of active tuberculosis.
16. Any serious acute and chronic infection requiring systemic antibacterial, antifungal
or antiviral therapy at screening, not including viral hepatitis.
17. Known history of human immunodeficiency virus (HIV) infection.
18. Previously receiving allogeneic stem cell or solid organ transplantation.
20. Known history of serious allergy to any monoclonal antibody, anti-angiogenesis targeted
drug.
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