Hepatocellular CarcinomaPhase 2NCT04172571
A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)
A Phase 2 study testing AK105 and Anlotinib Hydrochloride in people with Hepatocellular Carcinoma, run by Akeso at 1 site in China.
Trial summary
This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- AK105 and Anlotinib Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2018to 8 Jul 2022
- 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
- Signed written informed consent form voluntarily.
- Male or female，age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- Expected life expectance ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Confirmation either by histology unresectable hepatocellular carcinoma..
- BCLC stage C, and non-resectable BCLC stage B .
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- No prior systemic therapy for HCC.
- Child-Pugh class A and B (≤7 points).
- At least one measurable lesion according to RECIST criteria.
- Adequate hematologic and end-organ function.
- For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.
Who cannot join
- Prior treatment with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
- Active ongoing infection requiring therapy.
- History of severe hypersensitivity reaction to another monoclonal antibody.
- Received any live attenuated vaccine within the last 30 days.
- Other malignancy requiring treatment in the prior 5 years with the exception of locally treated squamous or basal cell carcinoma.
- Pregnant, breast feeding, or planning to become pregnant.
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- Active or prior documented autoimmune or inflammatory disease with some exceptions.
- Central nervous system metastases and/or carcinomatous meningitis.
- Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication.
- Co-infection of HBV and HCV.
- Inadequately controlled arterial hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Multi-Center Phase Ib/II Study of the Combination of AK105 and Anlotinib Hydrochloride in the First-Line Treatment of Patients With Unresectable Hepatocellular Carcinoma
This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AK105, Anlotinib Hydrochloride
- Keywords
- VEGF, Anti-PD-1, Tyrosine Kinase Inhibitor (TKI), Angiogenesis-related kinases
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK105Biological
Anti-PD-1 antibody; IV infusion, 200 mg Q3W
Anlotinib HydrochlorideDrug
multi-targeted receptor TKI; oral administration; every 3 weeks as one cycle administered as 2 weeks on/1 week off
| Study group | Role | What they receive |
|---|---|---|
| AK105 and anlotinib | Experimental | Not described Receives: Biological: AK105; Drug: Anlotinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
Measured: up to approximately 18 months
Secondary outcomes (7)
Number of subjects experiencing adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: From the time of informed consent through 90 days after last dose of AK105
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: up to approximately 18 months
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
Measured: up to approximately 18 months
Progression-free survival (PFS)
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Measured: up to approximately 18 months
Overall survival (OS)
OS is the time from the date of first dosing to death due to any cause.
Measured: up to approximately 24 months
Observed concentrations of AK105
The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
Measured: From first dose of AK105 through 90 days after last dose of AK105
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Measured: From first dose of AK105 through 90 days after last dose of AK105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start22 Nov 2018
- Primary completion1 Jun 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Responsible party
- Sponsor
- Investigators
- Shunchang Jiao, MD, Principal investigator, Chinese PLA General HospitalLi Bai, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172571
- Sponsor's protocol ID
- AK105-203
- Status last verified
- May 2024
- First submitted
- 19 Nov 2019
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Z, Pang X, Zhong T, Qu T, Chen N, Ma S, He X, Xia D, Wang M, Xia M, Li B. Penpulimab, an Fc-Engineered IgG1 Anti-PD-1 Antibody, With Improved Efficacy and Low Incidence of Immune-Related Adverse Events. Front Immunol. 2022 Jun 27;13:924542. doi: 10.3389/fimmu.2022.924542. eCollection 2022.
PubMed 35833116Han C, Ye S, Hu C, Shen L, Qin Q, Bai Y, Yang S, Bai C, Zang A, Jiao S, Bai L. Clinical Activity and Safety of Penpulimab (Anti-PD-1) With Anlotinib as First-Line Therapy for Unresectable Hepatocellular Carcinoma: An Open-Label, Multicenter, Phase Ib/II Trial (AK105-203). Front Oncol. 2021 Jul 13;11:684867. doi: 10.3389/fonc.2021.684867. eCollection 2021.
PubMed 34327136
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multi-Center Phase Ib/II Study of the Combination of AK105 and Anlotinib Hydrochloride in the First-Line Treatment of Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04172571
- Acronym / sponsor ID
- AK105-203
- Conditions
- Hepatocellular Carcinoma
- Keywords
- VEGF, Anti-PD-1, Tyrosine Kinase Inhibitor (TKI), Angiogenesis-related kinases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 21 Nov 2019 (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 a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable 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 |
|---|---|---|
| AK105 and anlotinib | Experimental | Biological: AK105, Drug: Anlotinib Hydrochloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent form voluntarily.
- Male or female，age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- Expected life expectance ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Confirmation either by histology unresectable hepatocellular carcinoma..
Key exclusion criteria (11 listed)
- Prior treatment with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
- Active ongoing infection requiring therapy.
- History of severe hypersensitivity reaction to another monoclonal antibody.
- Received any live attenuated vaccine within the last 30 days.
- Other malignancy requiring treatment in the prior 5 years with the exception of locally treated squamous or basal cell carcinoma.
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 |
|---|---|---|
| AK105Anti-PD-1 antibody; IV infusion, 200 mg Q3W | Biological | AK105 and anlotinib |
| Anlotinib Hydrochloridemulti-targeted receptor TKI; oral administration; every 3 weeks as one cycle administered as 2 weeks on/1 week off | Drug | AK105 and anlotinib |
Primary outcome
Objective response rate (ORR)
Time frame: up to approximately 18 months
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
7 secondary outcomes
Number of subjects experiencing adverse events (AEs)
Time frame: From the time of informed consent through 90 days after last dose of AK105
Duration of response (DoR)
Time frame: up to approximately 18 months
Disease control rate (DCR)
Time frame: up to approximately 18 months
Progression-free survival (PFS)
Time frame: up to approximately 18 months
Overall survival (OS)
Time frame: up to approximately 24 months
Observed concentrations of AK105
Time frame: From first dose of AK105 through 90 days after last dose of AK105
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of AK105 through 90 days after last dose of AK105
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 35833116Huang Z, Pang X, Zhong T, Qu T, Chen N, Ma S, He X, Xia D, Wang M, Xia M, Li B. Penpulimab, an Fc-Engineered IgG1 Anti-PD-1 Antibody, With Improved Efficacy and Low Incidence of Immune-Related Adverse Events. Front Immunol. 2022 Jun 27;13:924542. doi: 10.3389/fimmu.2022.924542. eCollection 2022.
- Derived from this study: PubMed 34327136Han C, Ye S, Hu C, Shen L, Qin Q, Bai Y, Yang S, Bai C, Zang A, Jiao S, Bai L. Clinical Activity and Safety of Penpulimab (Anti-PD-1) With Anlotinib as First-Line Therapy for Unresectable Hepatocellular Carcinoma: An Open-Label, Multicenter, Phase Ib/II Trial (AK105-203). Front Oncol. 2021 Jul 13;11:684867. doi: 10.3389/fonc.2021.684867. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Shunchang Jiao, MD principal investigator
Chinese PLA General Hospital
Li Bai, MD principal investigator
Chinese PLA General Hospital
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 AK105 and Anlotinib Hydrochloride in people with Hepatocellular Carcinoma, run by Akeso 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 11 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: finished, as of the sponsor's last update on 30 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: up to approximately 18 months). 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 NCT04172571, which also lists 2 linked publications.
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 30 May 2024.