TQB2450 Plus Anlotinib as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection (ALTER-H006)

April 28, 2022 updated by: Xianhai Mao

An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of TQB2450 Plus Anlotinib as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection

This is An Open, Single Arm, Multicenter, Exploratory Phase II study, to evaluate the efficacy and safety of TQB2450 Plus anlotinib as adjuvant therapy in hepatocellular carcinoma(HCC) patients at high risk of recurrence after resection. The patients who are confirmed by Histology or cytology as HCC with high-risk recurrence after R0 liver resection will be enrolled. 18 cycles adjuvant treatment with TQB2450 Plus anlotinib can improve one-year recurrence free survival (RFS) rate of HCC patients after R0 surgical resection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

TQB-2450 is a humanized mAb of PD-L1 that prevents PD-L1 from binding to PD-1 and B7.1 receptors on the T cell surface, enabling T cells to restore immune activity and thus enhance the immune response. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and proliferative signaling.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410005
        • Recruiting
        • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntary participation and written informed consent; • Age: 18-75 years old; ECOG PS: 0-1; The expected survival is more than 3 months;
  • HCC patients underwent R0 liver resection 4~8 weeks before enrolled; the imaging examination confirmed no recurrence and metastasis according to the RECIST1.1;
  • The remaining liver volume must account for more than 40% of the standard liver volume (patients with cirrhosis), or more than 30% (patients without cirrhosis);
  • Histologically or cytologically diagnosed as HCC, with any of the following high-risk recurrence conditions: a)Multiple tumor nodules( ≥4 nodules); b)Portal vein tumor thrombosis (PVTT): tumor thrombus distal to the second branches of the portal vein (vp1) and tumor thrombus in the second branches of the portal vein (vp2); c) Portal vein tumor thrombus (PVTT): tumor thrombus in a branch of the hepatic vein (vv1) and tumor thrombus in the right, middle, or left hepatic vein trunk or the short hepatic vein (vv2);
  • Laboratory inspection met the following criteria: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×10^9/L, Platelet count (PLT) ≥ 75×10^9/L, White blood cell count (WBC) ≥ 3×10^9/L, Total bilirubin (TBIL) ≤ 2.0 × normal upper limit (ULN), Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 5.0 ×ULN, Serum creatinine (Cr) ≤ 1.5× ULN, Creatinine clearance rate (CCr) ≥ 60ml/min, International Prothrombin Standardization Ratio (INR) ≤ 1.5 or Prothrombin time (PT) extension < 4s, Thyroid-stimulating hormone (TSH) ≤ULN (patients can be enrolled if the FT3 and FT4 levels are normal);
  • Liver function status Child-Pugh grade A(5-6) with no hepatoencephalopathy;
  • The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill, or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.

Exclusion Criteria:

  • HCC with recurrence after the surgical resection until before enrollment;
  • A history of liver cancer resection within 6 months before this surgery;
  • Extrahepatic metastasis;
  • Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma, and fibrolamellar hepatocellular carcinoma;
  • Preoperative treatment with VEGF (R) inhibitors (Anlotinib, sorafenib, Lenvatinib, and so on) or immunomodulator such as anti PD-1, PD-L1, anti CTLA-4;
  • Tumor thrombus in the first branch of the portal vein(vp3), tumor thrombus extension to the trunk or the opposite side branch of the portal vein(vp4), tumor thrombus to the inferior vena cava(vv3);
  • Patients with chronic active HBV or HCV, HBV-DNA>1000IU/ml, HCV-RNA>1000 copy/ml; hepatitis B with hepatitis C infection;
  • Other adjuvant therapy after surgery (except antiviral therapy) ;
  • Patients with any severe and/or unable to control diseases;
  • The presence of unhealed incisions or fracture;
  • A history of gastrointestinal bleeding within 6 months before enrollment; abdominal fistula, gastrointestinal perforation, or abdominal abscess within 2 months before enrollment;
  • Standardization Ratio (INR) > 1.5 or Time of partial thrombin activation (APTT) >1.5 × ULN or undergoing thrombolysis or anticoagulation therapy;
  • Genetic or acquired bleeding and thrombosis tendency, such as hemophilia, coagulopathy, etc; Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
  • History of another malignancy tumor within 5 years or for now (except for local cancer already cured).
  • Patients with a history of immunodeficiency(or autoimmune disease), or other acquired congenital immunodeficiency diseases;
  • Local hormone therapy within 2 weeks before treatment;
  • Ascites of clinical significance (except for less of Ascites which is asymptomatic)
  • Received any live attenuated vaccine within 4 weeks of admission or during the study period;
  • Patients who are allergic to components of TQB2450 and anlotinib preparations;
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect the completion of the study according to investigators' judgment;
  • Failure to follow the study protocol for treatment or scheduled follow-up.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: TQB2450 injection combined with Anlotinib hydrochloride capsules
Drug: TQB2450 injection
TQB2450 is an injection in the form of 1200mg, ivgtt, q3W.
Drug: Anlotinib hydrochloride capsules
Anlotinib Hydrochloride is a capsule in the form of 8 mg,10 mg, and 12 mg, orally, once daily, 2 weeks on/1 week off.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1-year Recurrence-free survival (RFS) rate
Time Frame: 1 year after treatment
1-year RFS rate is defined as the percentage of patients who do not experience tumor recurrence or death from any cause after 1-year treatment. 1-year RFS rate is determined according to the RECIST 1.1.
1 year after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events (AE)
Time Frame: 13 months
An AE refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v5.0 were recorded.
13 months
1-year Overall survival (OS) rate
Time Frame: 1 year after treatment
1-year OS rate is defined as the percentage of patients who do not experience death from any cause after 1-year treatment.
1 year after treatment
Recurrence-free survival (RFS)
Time Frame: 24 months
From the date of treatment to the date of diagnosis of tumor recurrence or death from any cause as determined by RECIST 1.1.
24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xianhai Mao

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20210727

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.

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