Last updated: July 23, 2021
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Liver Disorders
Liver Cancer
Abdominal Cancer
Treatment
N/AClinical Study ID
NCT04639284
COMOHCC
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Documented diagnosis of HCC confirmed by histology/cytology or clinical diagnosis ofHCC by Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019edition) criteria.
- Unresectable or advanced disease at the investigator's discretion. The advanced stagewas BCLC C stage or China Liver Cancer Stage IIIa or IIIb.
- Child-Pugh class A or B7.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Subjects received combination therapy with an anti-angiogenic agent and ananti-PD-1/PD-L1 antibody, received at least one imaging evaluation, and signed anInformed Consent Form. Anti-angiogenic agents include sorafenib, lenvatinib, apatinib,and bevacizumab; anti-PD-1/PD-L1 antibodies include pembrolizumab, nivolumab,sintilimab, toripalimab, camrelizumab, tislelizumab, and atezolizumab.
- Adequate hematologic and end-organ function.
Exclusion
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- History of malignancy other than HCC within 5 years prior to the therapy, with theexception of adequately treated carcinoma in situ of the cervix, non-melanoma skincarcinoma, or papillary thyroid carcinoma.
- History of organ transplantation or hepatic encephalopathy.
- Allergic to anti-angiogenic agents or anti-PD-1/PD-L1 agents.
- History of gastrointestinal perforation and/or fistula within the 6 months, a historyof intestinal obstruction (including incomplete intestinal obstruction requiringparenteral nutrition), extensive bowel resection, Crohn's disease, ulcerative colitis,or chronic diarrhea within 6 months.
- Active autoimmune disease requiring systemic therapy within 2 years prior to the firstdose, allowing the use of alternative therapies (e.g., thyroxine, insulin, orphysiologic corticosteroids for adrenal or pituitary insufficiency); history ofprimary immunodeficiency; presence of only autoimmune antibody-positive subjects. Thepresence of autoimmune disease needs to be confirmed at the investigator's discretion.
- Uncontrollable hypertension, SBP >140 mmHg or DBP >90 mmHg after optimal medicaltherapy, hypertensive crisis, or history of hypertensive encephalopathy.
- Subjects had a bleeding event in the past 6 months due to esophageal or gastric fundusvarices induced by portal venous hypertension; subjects have undergone agastrointestinal endoscopy within 3 months prior to the first dose to diagnose thepresence of severe (G3) varices; subjects had a high risk of bleeding as assessed bythe investigator.
- Subject requests withdrawal of informed consent.
- Other conditions that the investigator deems inappropriate for participation in thisstudy.
Study Design
Total Participants: 200
Study Start date:
December 23, 2020
Estimated Completion Date:
July 31, 2023
Study Description
Connect with a study center
Zhongshan Hospital, Fudan University
Shanghai, Shanghai 200032
ChinaActive - Recruiting
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