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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