Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors
NCT ID: NCT06031480
Last Updated: 2023-09-11
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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NOT_YET_RECRUITING
PHASE2
55 participants
INTERVENTIONAL
2023-10-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anlotinib+TQB2450
Anlotinib and TQB2450
Anlotinib: 10mg PO, QD, D1-14, Q3W; TQB2450: 1200 mg, IV, D1, Q3W.
Anlotinib and TQB2450 will be administered until the disease progression, intolerable toxicity, death, withdrawal of consent.
Interventions
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Anlotinib and TQB2450
Anlotinib: 10mg PO, QD, D1-14, Q3W; TQB2450: 1200 mg, IV, D1, Q3W.
Anlotinib and TQB2450 will be administered until the disease progression, intolerable toxicity, death, withdrawal of consent.
Eligibility Criteria
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Inclusion Criteria
* Hepatocellular carcinoma patients confirmed by pathological or cytological examination, or who meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of primary hepatocellular carcinoma" (2022)
* At least one measurable lesion (RECIST 1.1)
* Chinese Liver Cancer Staging (CNLC): CNLC-IIa, IIb, IIIa, IIIb (BCLC-B and C) that are not suitable for local treatment (TACE, HAIC, etc.) or that have progressed after local treatment
* The previous treatment plan for patients before enrollment was a standard treatment plan containing immune checkpoint inhibitors, and patients with progression or intolerance were evaluated based on the RECIST v1.1 standard
* Child-Pugh Score, Class A or better B
* ECOG performance status 0 or 1
* Adequate organ function
* Life expectancy of at least 3 months
Exclusion Criteria
* Patients who have received ≥ 2 treatments with immune checkpoint inhibitor regimens
* Adverse events above level 1(NCI-CTCAE v5.0) caused by any previous treatment that have not returned to ≤ level 1 (excluding hair loss); Patients with previous severe immune-related AEs requiring permanent cessation of immunotherapy
* Pregnant or lactating wome
18 Years
80 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Jia Fan
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Zhongshan hospital
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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KY2023297
Identifier Type: -
Identifier Source: org_study_id
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