AzTrials
AzTrials

Advanced Hepatocellular CarcinomaPhase 1NCT05975645

A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).

A Phase 1 study testing Penpulimab injection, TQB2618 injection and Anlotinib Hydrochloride Capsules in people with Advanced Hepatocellular Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 8 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQB2618 injection combined with penpulimab injection and Anlotinib Hydrochloride Capsules in patients with advanced HCC. 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?
Penpulimab injection, TQB2618 injection and Anlotinib Hydrochloride Capsules
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
8 sitesChina
Study dates
15 Aug 2023to 4 Jun 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

  • 18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
  • Patients with HCC diagnosed by histopathological or cytological examination or in line with clinical diagnostic criteria.
  • No systematic treatment for advanced HCC has been received before.
  • China liver cancer staging (CNLC)stage III or Barcelona Clinic Liver Cancer (BCLC) stage C, or CNLC stage II (BCLC B) subjects who are not suitable for local treatment and surgical treatment, or who are judged by researchers to be unable to benefit from local treatment and surgical treatment.
  • Liver function score was good.
  • Hepatitis B surface antigen (HBsAg) positive patients must meet hepatitis B virus deoxyribonucleic acid (HBV DNA) quantification < 10000 IU / ml (or 50000 copy/ml), and anti-HBV therapy should be given for at least 1 week before the first administration; investigator needs to determine that hepatitis C virus (HCV) infection is in a stable state.
Show all 12Show fewer
  • Patients after local treatment should be administered at least 4 weeks after the end of local treatment and have fully recovered from treatment toxicity and/or complications.
  • Radiotherapy for bone metastases accompanied by clinical symptoms must be completed at least 2 weeks before the first administration.
  • Has at least one measurable lesion.
  • The Main organ function is normal.
  • Men and women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Serum human chorionic gonadotropin (HCG) test is not negative within 7 days before the first administration and must be non-lactating patients.
  • Voluntary and signed informed consent, good compliance.

Who cannot join

  • Combined disease and medical history :
  • Other malignant tumors had appeared or were suffering from at the same time within 3 years before the first administration.
  • Unrelieved toxic reactions higher than grade 1 due to any previous treatment.
  • Major surgical treatment, obvious traumatic injury, or long-term unhealed wounds or fractures were received within 28 days before the first administration.
  • Patients who had any bleeding or bleeding events ≥grade 3 within 8 weeks before the first administration, or had arterial/venous thrombosis events within 6 months before the first administration.
  • There was a history of gastrointestinal bleeding within 6 months before the first administration; other conditions that may cause gastrointestinal bleeding or perforation.
Show all 28Show fewer
  • Patients with portal hypertension have a high risk of bleeding, or gastroscopy confirmed red sign or severe esophageal and gastric varices.
  • Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms.
  • Have a history of mental drug abuse that cannot be withdrawn, or have a mental disorder.
  • Patients who had previously received or planned to receive allogeneic bone marrow transplantation or solid organ transplantation within 6 months.
  • Have a history of hepatic encephalopathy.
  • Currently using or recently used aspirin (>325mg/day) or dipyridamole, ticlopidine, clopidogrel, and cilostazol treatment.
  • Have any heavy and/or uncontrolled disease.
  • Tumor-related, previous, and current treatment:
  • Histopathology or cytology confirmed as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatobiliary cell carcinoma, mixed liver cancer, etc. Clinically considered as hepatobiliary mixed tumor.
  • According to imaging examination, there was portal vein tumor thrombus involving the trunk; or inferior vena cava tumor thrombus or heart involvement.
  • Subjects have been treated with immune checkpoint inhibitors such as programmed cell death protein 1 (PD-1), Programmed cell death 1 ligand 1(PD-L1), T cell immunoglobulin and mucin domain containing protein 3 (TIM-3), etc.
  • Previously received any type of cellular immunotherapy.
  • Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Suffering from spinal cord compression, cancerous meningitis, with symptoms of brain metastasis or symptoms control time less than 4 weeks.
  • Study-related treatment:
  • There was a history of attenuated live vaccine inoculation within 28 days before the first administration, or attenuated live vaccine inoculation was planned during the study period.
  • Severe hypersensitivity reaction occurred after using macromolecular drugs.
  • Those with multiple factors affecting the oral administration of drugs.
  • Active autoimmune diseases requiring systemic treatment occurred within 2 years before the first administration.
  • immunodeficiency, or Undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy.
  • Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration.
  • According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510600

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • Third Affiliated Hospital of Naval Medical University

    Shanghai, Shanghai Municipality, 200433

  • The First People's Hospital of Shangqiu City

    Shangqiu, Henan, 476100

  • The six people's Hospital of Shenyang

    Shenyang, Liaoning, 110000

  • Gansu Wuwei Cancer Hospital

    Wuwei, Gansu, 733099

  • Affiliated hospital of zunyi medical university

    Zunyi, Guizhou, 563099

Other trials in China

About this study

Official title: A Phase Ib Clinical Study to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules as First-line Treatment for Advanced Hepatocellular Carcinoma.

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQB2618 injection combined with penpulimab injection and Anlotinib Hydrochloride Capsules in patients with advanced HCC.

Being tested
Penpulimab injection, TQB2618 injection, Anlotinib Hydrochloride Capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Penpulimab injectionDrug

    Penpulimab is an inhibitor of programmed cell death 1 (PD-1).

  • TQB2618 injectionDrug

    TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM-3).

  • Anlotinib Hydrochloride CapsulesDrug

    Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Study groups in NCT05975645
Study groupRoleWhat they receive
TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride CapsulesExperimentalIntravenous infusion of TQB2618 Injection 1200mg and Penpulimab Injection 200mg on 1st day, combining with Anlotinib capsules 10mg given orally in fasting conditions once daily in each 21-day cycle. (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Receives: Drug: Penpulimab injection; Drug: TQB2618 injection; Drug: Anlotinib Hydrochloride Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    Percentage of subjects achieving complete response (CR) and partial response (PR).

    Measured: Up to 2 years.

Secondary outcomes (9)

  1. Overall Survival (OS)

    OS is defined as the time from the first time the subject received treatment to death due to any cause.

    Measured: Up to two and a half years.

  2. Progress Free Survival (PFS)

    The time from the first administration of the drug to disease progression or death (whichever occurs first).

    Measured: Up to 2 years.

  3. Disease Control Rate (DCR)

    Percentage of subjects achieving CR and PR and stable disease (SD) is greater than or equal to 4-6 weeks.

    Measured: Up to 2 years.

  4. Duration of Response (DOR)

    The time from the first assessment of the tumor's CR or PR to the disease's first progression or death from various causes.

    Measured: Up to 2 years.

  5. Incidence of Anti-Drug antibody (ADA)

    The incidence of ADA after the administration of TQB2618.

    Measured: Before administration on the first day of the 1st, 2nd, 4th, and 8th cycles, 30 days and 90 days after the last administration. Each cycle is 21 days.

  6. Incidence of neutralizing antibodies (Nab)

    The incidence of Nab after the administration of TQB2618.

    Measured: Before administration on the first day of the 1st, 2nd, 4th, and 8th cycles, 30 days and 90 days after the last administration. Each cycle is 21 days.

  7. Incidence of adverse events (AEs)

    All adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

    Measured: Baseline up to 2 years.

  8. Severity of adverse events (AEs)

    All adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

    Measured: Baseline up to 2 years.

  9. Incidence of Serious adverse events (SAEs)

    It refers to adverse medical events such as death, life-threatening, permanent, or serious disability or loss of function, hospitalization or prolonged hospitalization, and congenital abnormalities or birth defects after the subject receives the experimental drug.

    Measured: Baseline up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start15 Aug 2023
  3. Primary completion4 Jun 2025
  4. Study completion4 Jun 2025

Why it stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns

Resources

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05975645
Sponsor's protocol ID
TQB2618-AK105-Ib-04
Status last verified
Jun 2025
First submitted
27 Jul 2023
Last updated
12 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Penpulimab injection, TQB2618 injection and Anlotinib Hydrochloride Capsules in people with Advanced Hepatocellular Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 8 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 12 inclusion and 28 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Overall response rate (ORR) (time frame: Up to 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05975645.

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 12 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in