Status:
UNKNOWN
Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is an multi-center, single arm, exploratory study to evaluate the efficacy and safety of anlitinib combined with TQB2450 in patients with advanced hepatocellular carcinoma （HCC）who failed prior i...
Eligibility Criteria
Inclusion
- The participants must be required to sign an informed consent
- 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
- Patients who have received local treatment (including TACE, ablation, HAIC, radiotherapy) and are less than 1 month after enrollment
- 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
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06031480
Start Date
October 31 2023
End Date
December 31 2025
Last Update
September 11 2023
Active Locations (1)
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1
Zhongshan hospital
Shanghai, Shanghai Municipality, China, 200032