Advanced Hepatocellular CarcinomaPhase 1NCT06320080
Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma.
A Phase 1 study testing TQB2223 injection and Penpulimab Injection in people with Advanced Hepatocellular Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- TQB2223 injection and Penpulimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesChina
- Study dates
- 30 May 2024to 3 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410031
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Hubei Provincial Tumor Hospital
Wuhan, Hubei, 430079
About this study
Official title: Phase Ib Clinical Study Evaluating the Efficacy and Safety of TQB2223 Injection Combined With Penpulimab Injection in the Treatment of Advanced Hepatocellular Carcinoma
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.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- TQB2223 injection, Penpulimab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2223 injectionDrug
TQB2223 is an anti- lymphocyte activation gene-3 (LAG-3) antibody.
Penpulimab InjectionDrug
Penpulimab Injection is an anti programmed death-1 (PD-1) antibody.
| Study group | Role | What they receive |
|---|---|---|
| TQB2223 injection+ AK105 Injection | Experimental | TQB2223 injection combined with AK105 (Penpulimab) injection, once every three weeks. 21 days as a treatment cycle. Receives: Drug: TQB2223 injection; Drug: Penpulimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The percentage of subjects with Complete Response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Modified Response Evaluation Criteria In Solid Tumors (iRECIST).
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.
Progression-free survival (PFS)
The time from the first dose of TQB2223 to the first occurrence of disease progression or death from any cause.
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Secondary outcomes (5)
Overall survival (OS)
The time from the first treatment to death from any cause.
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Disease control rate (DCR)
The proportion of subjects with Complete response (CR), Partial response (PR), or Stable Disease (SD).
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Duration of Response (DOR)
The time from first documented response to documented disease progression or death.
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Number of patients with adverse events (AEs) and/or serious adverse events (SAEs)
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: From the time of informed consent to 28 days after the last dose
Immunogenicity
The occurence of Anti-drug antibody (ADA) after administration
Measured: within 1 hour before dose in the 1st, 2nd, 4th, and 8th cycle. 30 and 90 days after the last dose. 21 days as a treatment cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start30 May 2024
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Why it stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320080
- Sponsor's protocol ID
- TQB2223-AK105-Ib-01
- Status last verified
- Nov 2024
- First submitted
- 13 Mar 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Clinical Study Evaluating the Efficacy and Safety of TQB2223 Injection Combined With Penpulimab Injection in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06320080
- Acronym / sponsor ID
- TQB2223-AK105-Ib-01
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2223 injection+ AK105 Injection | Experimental | Drug: TQB2223 injection, Drug: Penpulimab InjectionTQB2223 injection combined with AK105 (Penpulimab) injection, once every three weeks. 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2223 injectionTQB2223 is an anti- lymphocyte activation gene-3 (LAG-3) antibody. | Drug | TQB2223 injection+ AK105 Injection |
| Penpulimab InjectionPenpulimab Injection is an anti programmed death-1 (PD-1) antibody. | Drug | TQB2223 injection+ AK105 Injection |
Primary outcome
Objective Response Rate (ORR)
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.
The percentage of subjects with Complete Response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Modified Response Evaluation Criteria In Solid Tumors (iRECIST).
Progression-free survival (PFS)
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
The time from the first dose of TQB2223 to the first occurrence of disease progression or death from any cause.
5 secondary outcomes
Overall survival (OS)
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Disease control rate (DCR)
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Duration of Response (DOR)
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Number of patients with adverse events (AEs) and/or serious adverse events (SAEs)
Time frame: From the time of informed consent to 28 days after the last dose
Immunogenicity
Time frame: within 1 hour before dose in the 1st, 2nd, 4th, and 8th cycle. 30 and 90 days after the last dose. 21 days as a treatment cycle.
Results and safety
The study was stopped early (reason given: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2223 injection and Penpulimab Injection in people with Advanced Hepatocellular Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.