| Eligibility |
Inclusion Criteria:
1. volunteered with written inform consent
2. unresectable HCC or progression after surgery or locoregional threapy, with the
diagnosis confirmed by histologic or cytologic analysis or clinical features according
to the American Association for the Study of Liver Diseases practice guidelines and
the China liver cancer (CNLC) guidelines
3. Patients with portal vein tumor thrombosis (PVTT) confirmed by 2 kinds of imaging
examinations
4. no previous systemic therapy for HCC. Herbs, Chinese medicines or proprietary Chinese
medicines that contain anti-cancer active ingredients in the instructions are allowed,
but such treatments need to be terminated before randomization
5. at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1
6. patients who had previously received local treatments (such as radiofrequency
ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity
focused ultrasound, trans-arterial chemoembolization, trans-arterial embolization,
etc.)were allowed to be enrolled, but it was required that the target lesions were
with no previous local treatment, or the target lesion had received local treatment
but had progression according to the RECIST v1.1
7. an Eastern Cooperative Oncology Group performance status of 0 to 1
8. Child-Pugh A class liver function
9. adequate organ function (absoluteneutrophil count =1.5 × 109/L, platelet count =75 ×
109/L, hemoglobin = 90g/L, ALB=30g/L, TBIL =30 umol/L, AST =5×ULN, ALT =5×ULN, ALP
=5×ULN, Cr =1.5×ULN, TSH=1×ULN and TSH=LLN, INR=2.3, prolonged PT=6s without
anticoagulant therapy, urine protein <2+ or urine protein =2+ but 24h urine protein
quantitative <1.0 g)
10. patients with HBsAg (+) received anti-viral therapy, and patients with HCV-RNA (+)
must received anti-viral therapy according to the guidelines and the liver function
increases within CTCAE grade 1 during the study
11. Female with fertility must agree to use reliable methods of contraception from the
signing of the informed consent until at least 120 days after the last administration
of the study drug. And the serum HCG test must be negative within 7 days before the
start of the study treatment; and it must be a non-lactating period.
12. For male patients whose partner is a fertile woman, they must agree to use reliable
methods of contraception from the signing of the informed consent until at least 120
days after the last administration of the study drug. During the same period of time,
male patients must also agree not to donate sperm.
Exclusion Criteria:
1. intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and
fibrolamellar cell carcinoma diagnosised by pathology
2. patients with other malignant tumors except HCC within 5 years or at the same time,
except for cured localized tumors, such as skin basal cell carcinoma, skin squamous
cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical
carcinoma in situ, breast carcinoma in situ, etc.
3. patients who are planning to undergo or have previously received organ or allogeneic
bone marrow transplantation
4. history of hepatic encephalopathy
5. moderate and severe ascites with clinical symptoms and uncontrolled pleural effusion
and pericardial effusion
6. a history of gastrointestinal bleeding or a clear tendency to gastrointestinal
bleeding within 6 months before the start of the study treatment
7. a history of abdominal fistula, gastrointestinal perforation or abdominal abscess
occurred within 6 months before the start of study treatment
8. a known hereditary or acquired bleeding (such as coagulopathy) or thrombotic tendency
9. currently using or recently used (within 10 days before the start of the study
treatment) anticoagulant drugs
10. thrombosis or embolism occurred within 6 months before the start of study treatment,
such as cerebrovascular accident, pulmonary embolism
11. with clinical symptoms or diseases of the heart that are not well controlled
12. suffered from blood pressure that could not be well controlled by antihypertensive
medication or a history of hypertensive crisis or hypertensive encephalopathy
13. severe cardiovascular disease occurred within 6 months before the start of study
treatment
14. severe, unhealed or dehisced wounds and active ulcers or untreated fractures
15. received major surgery (except for diagnosis) within 4 weeks before the start of the
study treatment or is expected to undergo major surgery during the study period
16. unable to swallow pills, malabsorption syndrome, or any condition that affects
gastrointestinal absorption
17. a history intestinal obstruction, and/or clinical signs or symptoms of
gastrointestinal obstruction that were not relieved after the medical treatment within
6 months before start of the study treatment
18. evidence of intra-abdominal gas that cannot be explained by puncture or recent surgery
19. a history of or current central nervous system metastases
20. a history of or current pulmonary fibrosis, organizing pneumonia and other active
pneumonia, or severely impaired lung function, which may interfere with the detection
and treatment of suspected drug-related lung toxicity
21. any active autoimmune disease or a history of autoimmune disease which are expected
recurrence (including but not limited to: autoimmune hepatitis, interstitial
pneumonia, uveitis, etc.), except for immune diseases that do not require medical
treatment, such as vitiligo, psoriasis, asthma, and well-controlled type I diabetes,
etc.
22. patients undergoing immunosuppressive agents or systemic hormone therapy to achieve
immunosuppressive purposes, and continues to use it within 2 weeks before signing the
informed consent
23. received treatment with a live attenuated vaccine within 28 days before the start of
the study treatment, or expected to be vaccinated during camrelizumabtreatment or
within 60 days after the last dose of camrelizumab
24. active tuberculosis
25. congenital or acquired immune deficiencies (such as HIV-infected)
26. combined hepatitis B and hepatitis C co-infection
27. patients who are known to be allergic to study drugs or excipients have a history of
allergies
28. palliative radiotherapy for non-target lesions for symptom control within 2 weeks
before the start of study treatment, or adverse events caused by radiotherapy did not
recover to = CTCAE grade 1 (except for alopecia)
29. perform locoreginal treatments of the liver within 28 days before start of the study
treatment (such as radiofrequency ablation, percutaneous ethanol or acetic acid
injection, cryoablation, high-intensity focused ultrasound, transarterial
chemoembolization, transarterial embolization, etc.), or adverse reactions caused by
previous locoreginal treatments have not recovered to = CTCAE level 1 (except for
alopecia etc.)
30. according to the judgment of the investigator, the patients with factors that may
affect the results of the study or cause the study to be terminated midway, such as
alcoholism, drug abuse, other serious diseases (including mental illness) need to be
treated together, severe laboratory abnormalities, accompanied by family or social
factors, which will affect the safety of patients
31. patients who is pregnant or breastfeeding
32. other factors that the investigatior considers inappropriate to participate in the
study
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