Hepatocellular CarcinomaPhase 2ALTER-H006NCT05111366
TQB2450 Plus Anlotinib as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection
A Phase 2 study testing TQB2450 injection and Anlotinib hydrochloride capsules in people with Hepatocellular Carcinoma and Adjuvant Therapy, run by Xianhai Mao at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Adjuvant Therapy
- What is being tested?
- TQB2450 injection and Anlotinib hydrochloride capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2022to 20 May 2024
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan, 410005
Xianhai Mao, PhD, 0086-15874957968, 927011715@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Adjuvant Therapy
- Being tested
- TQB2450 injection, Anlotinib hydrochloride capsules
- Keywords
- HCC, Adjuvant Therapy, TQB2450, Anlotinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450 injectionDrug
TQB2450 is an injection in the form of 1200mg, ivgtt, q3W.
Anlotinib hydrochloride capsulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TQB2450 injection combined with Anlotinib hydrochloride capsules | Experimental | Not described Receives: Drug: TQB2450 injection; Drug: Anlotinib hydrochloride capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Recurrence-free survival (RFS) rate
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.
Measured: 1 year after treatment
Secondary outcomes (3)
Adverse events (AE)
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.
Measured: 13 months
1-year Overall survival (OS) rate
1-year OS rate is defined as the percentage of patients who do not experience death from any cause after 1-year treatment.
Measured: 1 year after treatment
Recurrence-free survival (RFS)
From the date of treatment to the date of diagnosis of tumor recurrence or death from any cause as determined by RECIST 1.1.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start6 Jan 2022
- Primary completion20 Jan 2024 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xianhai Mao
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor-investigator, Xianhai Mao, Hunan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111366
- Sponsor's protocol ID
- 20210727
- Acronym
- ALTER-H006
- Status last verified
- Apr 2022
- First submitted
- 27 Oct 2021
- Last updated
- 4 May 2022
- 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05111366
- Acronym / sponsor ID
- ALTER-H006 / 20210727
- Conditions
- Hepatocellular Carcinoma, Adjuvant Therapy
- Keywords
- HCC, Adjuvant Therapy, TQB2450, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Xianhai MaoUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 8 Nov 2021 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2450 injection combined with Anlotinib hydrochloride capsules | Experimental | Drug: TQB2450 injection, Drug: Anlotinib hydrochloride capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (21 listed)
- 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;
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 |
|---|---|---|
| TQB2450 injectionTQB2450 is an injection in the form of 1200mg, ivgtt, q3W. | Drug | TQB2450 injection combined with Anlotinib hydrochloride capsules |
| Anlotinib hydrochloride capsulesAnlotinib Hydrochloride is a capsule in the form of 8 mg,10 mg, and 12 mg, orally, once daily, 2 weeks on/1 week off. | Drug | TQB2450 injection combined with Anlotinib hydrochloride capsules |
Primary outcome
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.
3 secondary outcomes
Adverse events (AE)
Time frame: 13 months
1-year Overall survival (OS) rate
Time frame: 1 year after treatment
Recurrence-free survival (RFS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB2450 injection and Anlotinib hydrochloride capsules in people with Hepatocellular Carcinoma and Adjuvant Therapy, run by Xianhai Mao at 1 site 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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianhai Mao, PhD (0086-15874957968, 927011715@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Recurrence-free survival (RFS) rate (time frame: 1 year after treatment). 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 4 May 2022.