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Trial Title: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma.

NCT ID: NCT06320080

Condition: Advanced Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TQB2223 injection
Description: TQB2223 is an anti- lymphocyte activation gene-3 (LAG-3) antibody.
Arm group label: TQB2223 injection+ AK105 Injection

Intervention type: Drug
Intervention name: Penpulimab Injection
Description: Penpulimab Injection is an anti programmed death-1 (PD-1) antibody.
Arm group label: TQB2223 injection+ AK105 Injection

Summary: TQB2223 is a recombinant, fully human antibody that binds to lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase Ib study aimed at evaluating the safety, tolerability, and immunogenicity characteristics of TQB2223 injection combined with AK105 injection in the treatment of advanced hepatocellular carcinoma.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 18 to 75 years old, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥3 months; - Hepatocellular carcinoma (HCC) patients confirmed by pathological histology or cytology examination or meeting the clinical diagnostic criteria for hepatocellular carcinoma according to the American Association for the Study of Liver Diseases (AASLD) or the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 edition); - Have not received any immunotherapy for advanced HCC previously; - Subjects with a China liver cancer staging (CNLC) of stage III [or Barcelona clinical staging of liver cancer (BCLC) of stage C], or CNLC-II (BCLC-B) subjects who are not suitable for local treatment (such as hepatic artery chemotherapy and embolization) and surgical treatment, or cannot benefit from local treatment and surgical treatment as determined by the investigators; - Child Pugh liver function grading: Grade A or B (≤ 7 points) - Subjects with advanced malignant tumors who failed standard treatment or lacked effective treatment; - The main organs function well; - Male or female patient had no plans to become pregnant and agree to voluntarily take effective contraceptive measures during the study to at least 6 months after the last dose of study drug. Exclusion Criteria: - Concurrent secondary malignancy or other malignancy with no evidence of disease within 5 years prior to the first dose; - Within 28 days prior to the first dose, received significant surgical treatment, or with obvious traumatic injury or long-term unhealed wound or fracture; - Patients who experienced any bleeding or bleeding events ≥ CTC AE level 3 within 4 weeks prior to the first dose; Individuals who have experienced arterial/venous thrombosis events within 6 months prior to the first dose, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism; Low molecular weight heparin treatment is allowed, and antiplatelet drugs are prohibited throughout the entire study period; - A history of gastrointestinal bleeding such as active gastric and duodenal ulcers, persistent positive fecal occult blood, and ulcerative colitis within 6 months prior to the first dose; Or other conditions determined by investigators that may cause gastrointestinal bleeding or perforation; - Patients with portal hypertension and at high risk of bleeding considered by the investigators, or have been confirmed by gastroscopy to have red signs or severe esophageal and gastric varicose veins. - Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders; - Individuals who have previously received or are preparing to undergo allogeneic bone marrow transplantation or solid organ transplantation within 6 months; - History of hepatic encephalopathy; - History of uncontrolled intercurrent illness; - Participants who have participated in other clinical trials of anti-tumor drugs and used other investigational anti-tumor drugs within 4 weeks prior to the first dose; - Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Affiliated Cancer Hospital of Harbin Medical University

Address:
City: Harbin
Zip: 150000
Country: China

Contact:
Last name: Zhiwei Li, Doctor

Phone: 15004683651
Email: lzhw0451@163.com

Facility:
Name: Hubei Provincial Tumor Hospital

Address:
City: Wuhan
Zip: 430079
Country: China

Contact:
Last name: Feng Zhang, Doctor

Phone: 13871410719
Email: zhangfeng_329@126.com

Facility:
Name: Hunan Provincial Tumor Hospital

Address:
City: Changsha
Zip: 410031
Country: China

Contact:
Last name: Shanzhi Gu, Master

Phone: 13574865998
Email: 105575191@qq.com

Start date: April 2024

Completion date: October 2025

Lead sponsor:
Agency: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class: Industry

Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06320080

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