Hepatocellular Carcinoma
Conditions
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 immune checkpoint inhibitor therapies.
Interventions
DRUGAnlotinib 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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR, RECIST v1.1) | 24 months | ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs |
Countries
China
Contacts
Primary ContactYinghao Shen
Backup ContactHuichuan Sun
Outcome results
None listed