Hepatocellular Carcinoma Non-resectablePhase 2NCT06375486
Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）.
A Phase 2 study testing Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） in people with Hepatocellular Carcinoma Non-resectable and Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma
- What is being tested?
- Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2024to 15 Jun 2026
- 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
- Voluntarily sign a written informed consent form.
- Age at enrollment is ≥ 18 years and ≤ 75 years, both males and females are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥ 3 months.
- Confirmed histologically/cytologically or cirrhotic patients meeting the Barcelona Clinic Liver Cancer (BCLC) stage B or C criteria for hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria.
- Not suitable for curative treatment (surgery or ablation) and have not previously received systemic anti-tumor therapy for unresectable HCC.
- Liver function classified as Child-Pugh class A.
- Sufficient organ function.
Who cannot join
- Components including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc., confirmed histologically/cytologically.
- Apart from HCC, subjects have had other malignant tumors within 5 years prior to enrollment. Subjects who have been cured of other malignant tumors through local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. If diagnosed with liver cancer or other malignant tumors more than 5 years before dosing, pathological histology or cytology diagnosis of recurrent metastatic lesions is required.
- Poor compliance, unable to cooperate and describe treatment responses.
- History of past or current central nervous system (CNS) metastasis or leptomeningeal metastasis.
- Presence of extrahepatic metastasis.
- History of hepatic encephalopathy or liver transplantation.
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- Clinical symptoms or recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.
- History of or current non-infectious pneumonia or interstitial lung disease requiring systemic corticosteroid therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Huikai Li, Doctor, 18622228639, tjchlhk@126.com
Yang Liu, MD, 17694950696, tjchlhk@126.com
About this study
Official title: A Single-arm, Single-center, Phase II Clinical Study of AK112 (a Dual-specific Antibody Against PD-1/VEGF) Combined With Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma.
This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.
All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first.
Read the detailed description
This study is a single-center, open-label Phase II clinical trial, planning to enroll approximately 30 Chinese subjects with unresectable BCLC stage B or C hepatocellular carcinoma (HCC). The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.
All enrolled subjects will receive AK112 (20mg/kg Q3W) in combination with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging assessment and clinical evaluation), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever comes first.
The study consists of screening period (up to 28 days from subject signing informed consent form to the first dose), treatment period (including treatment visits during treatment and end-of-treatment visit), and follow-up period (including safety follow-up visits, disease progression follow-up visits, and survival follow-up). Subjects will undergo screening assessments within 28 days before the first dose to determine their eligibility for the study.
All subjects will undergo regular tumor response assessments, with objective response rate (ORR) evaluated by the investigator according to RECIST v1.1 and mRECIST criteria as the primary efficacy endpoint. Within the first 48 weeks after the initial dose, tumor assessments will be conducted every 6 weeks (±7 days), and after 48 weeks, assessments will be performed every 12 weeks (±7 days). If a subject discontinues study treatment for reasons other than disease progression or death, tumor assessments should continue according to a fixed schedule until radiographic progression or termination of study treatment (whichever occurs first), initiation of new anti-tumor therapy, loss to follow-up, death, withdrawal of informed consent, or study closure, whichever occurs first. Confirmation of objective response should occur at least 4 weeks after the initial documentation of response, and in cases of clinical stability, confirmation assessments can be performed at the next scheduled time point.
Adverse events (AEs) will be followed up to 30 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first. Serious adverse events (SAEs) will be followed up to 90 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first. Survival assessments will be conducted every 3 months after the last dose, and information on subsequent anti-tumor therapy will be collected after termination of study treatment.
- Being tested
- Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）Drug
Also called HAIC
All enrolled subjects will receive Ivonescimab（AK112，a PD-1/VEGF bispecific antibody，20mg/kg Q3W) in combination with HAIC (utilizing the FOLFOX chemotherapy regimen)
| Study group | Role | What they receive |
|---|---|---|
| AK112 arm | Experimental | The patients will receive AK112（PD-1/VEGF bispecific antibody）plus HAIC Receives: Drug: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Defined as proportion of patients who have a best response of CR or PR
Measured: up to 1 year
Secondary outcomes (3)
Progress Free Survival （PFS）
Defined as the time from enrollment to disease progression or death (whichever occurs first)
Measured: up to 2 years
Overall survival (OS)
OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
Measured: up to 2 years
Adverse Events（AEs）
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start14 Mar 2024
- Primary completion14 Mar 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375486
- Sponsor's protocol ID
- AK112-IIT-TianjinCIH-LHK
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 19 Apr 2024
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Phase II Clinical Study of AK112 (a Dual-specific Antibody Against PD-1/VEGF) Combined With Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT06375486
- Acronym / sponsor ID
- AK112-IIT-TianjinCIH-LHK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 19 Apr 2024 (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 study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.
All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first.
Detailed description
This study is a single-center, open-label Phase II clinical trial, planning to enroll approximately 30 Chinese subjects with unresectable BCLC stage B or C hepatocellular carcinoma (HCC). The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.
All enrolled subjects will receive AK112 (20mg/kg Q3W) in combination with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging assessment and clinical evaluation), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever comes first.
The study consists of screening period (up to 28 days from subject signing informed consent form to the first dose), treatment period (including treatment visits during treatment and end-of-treatment visit), and follow-up period (including safety follow-up visits, disease progression follow-up visits, and survival follow-up). Subjects will undergo screening assessments within 28 days before the first dose to determine their eligibility for the study.
All subjects will undergo regular tumor response assessments, with objective response rate (ORR) evaluated by the investigator according to RECIST v1.1 and mRECIST criteria as the primary efficacy endpoint. Within the first 48 weeks after the initial dose, tumor assessments will be conducted every 6 weeks (±7 days), and after 48 weeks, assessments will be performed every 12 weeks (±7 days). If a subject discontinues study treatment for reasons other than disease progression or death, tumor assessments should continue according to a fixed schedule until radiographic progression or termination of study treatment (whichever occurs first), initiation of new anti-tumor therapy, loss to follow-up, death, withdrawal of informed consent, or study closure, whichever occurs first. Confirmation of objective response should occur at least 4 weeks after the initial documentation of response, and in cases of clinical stability, confirmation assessments can be performed at the next scheduled time point.
Adverse events (AEs) will be followed up to 30 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first. Serious adverse events (SAEs) will be followed up to 90 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first. Survival assessments will be conducted every 3 months after the last dose, and information on subsequent anti-tumor therapy will be collected after termination of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK112 arm | Experimental | Drug: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）The patients will receive AK112（PD-1/VEGF bispecific antibody）plus HAIC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily sign a written informed consent form.
- Age at enrollment is ≥ 18 years and ≤ 75 years, both males and females are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥ 3 months.
- Confirmed histologically/cytologically or cirrhotic patients meeting the Barcelona Clinic Liver Cancer (BCLC) stage B or C criteria for hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria.
Key exclusion criteria (9 listed)
- Components including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc., confirmed histologically/cytologically.
- Apart from HCC, subjects have had other malignant tumors within 5 years prior to enrollment. Subjects who have been cured of other malignant tumors through local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. If diagnosed with liver cancer or other malignant tumors more than 5 years before dosing, pathological histology or cytology diagnosis of recurrent metastatic lesions is required.
- Poor compliance, unable to cooperate and describe treatment responses.
- History of past or current central nervous system (CNS) metastasis or leptomeningeal metastasis.
- Presence of extrahepatic metastasis.
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 |
|---|---|---|
| Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）Also: HAICAll enrolled subjects will receive Ivonescimab（AK112，a PD-1/VEGF bispecific antibody，20mg/kg Q3W) in combination with HAIC (utilizing the FOLFOX chemotherapy regimen) | Drug | AK112 arm |
Primary outcome
Overall response rate (ORR)
Time frame: up to 1 year
Defined as proportion of patients who have a best response of CR or PR
3 secondary outcomes
Progress Free Survival （PFS）
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
Adverse Events（AEs）
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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 Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） in people with Hepatocellular Carcinoma Non-resectable and Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 8 inclusion and 9 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 19 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huikai Li, MD (18622228639, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 1 year). 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 19 Apr 2024.