Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors (FAITH)
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ClinicalTrials.gov Identifier: NCT06031480 |
Recruitment Status :
Not yet recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma | Drug: Anlotinib and TQB2450 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 55 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of Combination Treatment Using Anlotinib and TQB2450 in Patients With Advanced Hepatocellular Carcinoma Who Failed Prior Immune Checkpoint Inhibitor Therapies: a Single Arm, Multicenter Clinical Trial |
Estimated Study Start Date : | October 31, 2023 |
Estimated Primary Completion Date : | October 31, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: anlotinib+TQB2450 |
Drug: 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. |
- Objective response rate (ORR, RECIST v1.1) [ Time Frame: 24 months ]ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031480
Contact: Yinghao Shen | 0086-13916276098 | shen.yinghao@zs-hospital.sh.cn | |
Contact: Huichuan Sun | 0086-13701922065 | sun.huichuan@zs-hospital.sh.cn |
China, Shanghai | |
Zhongshan hospital | |
Shanghai, Shanghai, China, 200032 | |
Contact: Yinghao Shen +8613916276098 shen.yinghao@zs-hospital.sh.cn |
Principal Investigator: | Jia Fan | Shanghai Zhongshan Hospital |
Responsible Party: | Shanghai Zhongshan Hospital |
ClinicalTrials.gov Identifier: | NCT06031480 |
Other Study ID Numbers: |
KY2023297 |
First Posted: | September 11, 2023 Key Record Dates |
Last Update Posted: | September 11, 2023 |
Last Verified: | July 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |