Anti-angiogenic Agents Plus Anti-PD-1 Antibodies for uHCC
NCT ID: NCT04639284
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-12-23
2023-07-31
Brief Summary
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Detailed Description
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1. To evaluate the clinical effectiveness in real-world patients, especially for Chinese patients most of whom were with hepatitis B virus infection.
2. To predict clinical effectiveness with clinicopathological features, such as lab examinations (at baseline and dynamic changes), radiological features (radiomics study at the baseline);
3. To predict clinical effectiveness with histologic features, such as PD-L1 expression, ctDNA, and peripheral immune cell subtypes.
4. To evaluate the clinical effectiveness of second- or third-line therapies, including TACE, HAIC, and interferon, for those who lost clinical benefit or who were intolerant to the combination therapy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Combinational therapy
Participants who receive systemic treatment with an anti-angiogenic agent, including sorafenib, lenvatinib, apatinib, and bevacizumab, in combination with an anti-PD-1/PD-L1 antibody, including pembrolizumab, nivolumab, sintilimab, toripalimab, camrelizumab, tislelizumab, and atezolizumab.
Anti-angiogenic agents plus anti-PD-1/PD-L1 antibodies
Combination therapies with an anti-angiogenic agent (tyrosine kinase inhibitor or VEGF/VEGFR antibody) and an anti-PD-1/PD-L1 antibody.
Interventions
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Anti-angiogenic agents plus anti-PD-1/PD-L1 antibodies
Combination therapies with an anti-angiogenic agent (tyrosine kinase inhibitor or VEGF/VEGFR antibody) and an anti-PD-1/PD-L1 antibody.
Eligibility Criteria
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Inclusion Criteria
2. Unresectable or advanced disease at the investigator's discretion. The advanced stage was BCLC C stage or China Liver Cancer Stage IIIa or IIIb.
3. Child-Pugh class A or B7.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Subjects received combination therapy with an anti-angiogenic agent and an anti-PD-1/PD-L1 antibody, received at least one imaging evaluation, and signed an Informed 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.
6. Adequate hematologic and end-organ function.
Exclusion Criteria
2. History of malignancy other than HCC within 5 years prior to the therapy, with the exception of adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or papillary thyroid carcinoma.
3. History of organ transplantation or hepatic encephalopathy.
4. Allergic to anti-angiogenic agents or anti-PD-1/PD-L1 agents.
5. History of gastrointestinal perforation and/or fistula within the 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months.
6. Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose, allowing the use of alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency); history of primary immunodeficiency; presence of only autoimmune antibody-positive subjects. The presence of autoimmune disease needs to be confirmed at the investigator's discretion.
7. Uncontrollable hypertension, SBP \>140 mmHg or DBP \>90 mmHg after optimal medical therapy, hypertensive crisis, or history of hypertensive encephalopathy.
8. Subjects had a bleeding event in the past 6 months due to esophageal or gastric fundus varices induced by portal venous hypertension; subjects have undergone a gastrointestinal endoscopy within 3 months prior to the first dose to diagnose the presence of severe (G3) varices; subjects had a high risk of bleeding as assessed by the investigator.
9. Subject requests withdrawal of informed consent.
10. Other conditions that the investigator deems inappropriate for participation in this study.
18 Years
90 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Hui-Chuan Sun
Professor of Surgery
Principal Investigators
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Hui-Chuan Sun, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COMOHCC
Identifier Type: -
Identifier Source: org_study_id
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