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

March 4, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Wuwei, Gansu, China, 733099
        • Recruiting
        • Gansu Wuwei Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510600
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Guizhou
      • Zunyi, Guizhou, China, 563099
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • Affiliated Cancer Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Shangqiu, Henan, China, 476100
        • Recruiting
        • The First People's Hospital of Shangqiu City
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The six people's Hospital of Shenyang
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Third Affiliated Hospital of Naval Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • Combined disease and medical history :

    1. Other malignant tumors had appeared or were suffering from at the same time within 3 years before the first administration.
    2. Unrelieved toxic reactions higher than grade 1 due to any previous treatment.
    3. Major surgical treatment, obvious traumatic injury, or long-term unhealed wounds or fractures were received within 28 days before the first administration.
    4. 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.
    5. There was a history of gastrointestinal bleeding within 6 months before the first administration; other conditions that may cause gastrointestinal bleeding or perforation.
    6. Patients with portal hypertension have a high risk of bleeding, or gastroscopy confirmed red sign or severe esophageal and gastric varices.
    7. Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms.
    8. Have a history of mental drug abuse that cannot be withdrawn, or have a mental disorder.
    9. Patients who had previously received or planned to receive allogeneic bone marrow transplantation or solid organ transplantation within 6 months.
    10. Have a history of hepatic encephalopathy.
    11. Currently using or recently used aspirin (>325mg/day) or dipyridamole, ticlopidine, clopidogrel, and cilostazol treatment.
    12. Have any heavy and/or uncontrolled disease.

  • Tumor-related, previous, and current treatment:

    1. Histopathology or cytology confirmed as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatobiliary cell carcinoma, mixed liver cancer, etc. Clinically considered as hepatobiliary mixed tumor.
    2. According to imaging examination, there was portal vein tumor thrombus involving the trunk; or inferior vena cava tumor thrombus or heart involvement.
    3. 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.
    4. Previously received any type of cellular immunotherapy.
    5. Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
    6. Suffering from spinal cord compression, cancerous meningitis, with symptoms of brain metastasis or symptoms control time less than 4 weeks.

  • Study-related treatment:

    1. 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.
    2. Severe hypersensitivity reaction occurred after using macromolecular drugs.
    3. Those with multiple factors affecting the oral administration of drugs.
    4. Active autoimmune diseases requiring systemic treatment occurred within 2 years before the first administration.
    5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride Capsules
Intravenous 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)
Drug: Penpulimab injection
Penpulimab is an inhibitor of programmed cell death 1 (PD-1).
Drug: TQB2618 injection
TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM-3).
Drug: Anlotinib Hydrochloride Capsules
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: Up to 2 years.
Percentage of subjects achieving complete response (CR) and partial response (PR).
Up to 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to two and a half years.
OS is defined as the time from the first time the subject received treatment to death due to any cause.
Up to two and a half years.
Progress Free Survival (PFS)
Time Frame: Up to 2 years.
The time from the first administration of the drug to disease progression or death (whichever occurs first).
Up to 2 years.
Disease Control Rate (DCR)
Time Frame: Up to 2 years.
Percentage of subjects achieving CR and PR and stable disease (SD) is greater than or equal to 4-6 weeks.
Up to 2 years.
Duration of Response (DOR)
Time Frame: Up to 2 years.
The time from the first assessment of the tumor's CR or PR to the disease's first progression or death from various causes.
Up to 2 years.
Incidence of Anti-Drug antibody (ADA)
Time Frame: 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.
The incidence of ADA after the administration of TQB2618.
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.
Incidence of neutralizing antibodies (Nab)
Time Frame: 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.
The incidence of Nab after the administration of TQB2618.
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.
Incidence of adverse events (AEs)
Time Frame: Baseline up to 2 years.
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).
Baseline up to 2 years.
Severity of adverse events (AEs)
Time Frame: Baseline up to 2 years.
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).
Baseline up to 2 years.
Incidence of Serious adverse events (SAEs)
Time Frame: Baseline up to 2 years.
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.
Baseline up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2618-AK105-Ib-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Hepatocellular Carcinoma

Clinical Trials on Penpulimab injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe