Unrescetable Hepatocellular CarcinomaPhase 2NCT05821361
HAIC Combined With Cadonilimab and Bevacizumab as First-line Therapy in Unresectable Hepatocellular Carcinoma
A Phase 2 study testing HAIC+Cadonilimab+Bevacizumab in people with Unrescetable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of HAIC combined with Cadonilimab and bevacizumab as first-line therapy in Unresectable hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unrescetable Hepatocellular Carcinoma
- What is being tested?
- HAIC+Cadonilimab+Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2025
- 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
- written informed consent signed prior to enrolment.
- age 18-75 years, both sexes.
- Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by American Association for the Study of Liver Diseases (AASLD).
- ECOG PS of 0 or 1.
- Absence of systemic anti-tumor treatment for HCC before the first dose.
- Barcelona Clinic Liver Cancer (BCLC) stage of C. Stage B for those unsuitable for radical surgery and/or local treatment.
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- At least one measurable lesion according to RECIST V1.1, or measurable lesions showing definite progression following the local treatment based on RECIST V1.1.
- Child-Pugh score of ≤ 7.
- Sufficient organ and bone marrow functions, with the laboratory test values within 7 days before the enrollment meeting the following requirements (no blood components, cell growth factors, albumin, and other drugs via intravenous or subcutaneous administrations are allowed for correction treatment within the first 14 days after the laboratory test results are obtained). The specific information is as follows:
- 1) Routine blood test: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 75 × 10^9/L; hemoglobin (HGB) ≥ 9.0 g/dL.
- 2) Hepatic function: total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN; serum albumin ≥ 28 g/L; alkaline phosphatase (ALP) ≤ 5 × ULN. 3) Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or clearance of creatinine (CCr) ≥ 50 mL/min (Cockcroft-Gault formula); urinalysis results showing urine protein <2+; patients whose baseline urinalysis results show urine protein ≥ 2+ should undergo 24-h urine collection and 24-h urine protein quantitation test result should be < 1 g.
- 4) Blood coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- 10.Estimated survival ≥ 12 weeks. 11. Female patients of childbearing age or male patients with female sexual partners of childbearing age should take effective contraceptive measures throughout the treatment and 6 months after the last dose.
Who cannot join
- Histologically/cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma.
- History of hepatic encephalopathy or liver transplantation.
- Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.
- Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA > 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA > 103 copies/mL; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive concurrently. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled.
- Presence of metastasis to the central nervous system.
- Presence of bleeding events from esophageal or gastric varices caused by portal hypertension within the past 6 months. Presence of known severe (G3) varicose vein in endoscopy within 3 months before the first dose. Evidence of portal hypertension (including the finding of splenomegaly in imaging studies) with a high risk of bleeding assessed by the investigator.
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- Presence of any life-threatening bleeding events within the past 3 months, including the need for transfusion, surgery or local treatment, and continuous medication therapy.
- Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently. Presence of tumor thrombus of inferior vena cava.
- A 10-day consecutive dosing of aspirin (> 325 mg/day) or other drugs, e.g., dipyridamole and clopidogrel, known to inhibit the platelet function within 2 weeks before the first dose.
- History or current experience of pulmonary fibrosis and such lung diseases as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severely impaired lung function.
- Uncontrolled/uncorrectable metabolic disorders, other non-malignant organ diseases, systemic diseases, or cancer-related secondary diseases with the potential to cause a relatively high medical risk and/or survival evaluation uncertainties unsuitable for subject enrollment as judged by the investigator; other circumstances unsuitable for subject enrollment as judged by the investigator.
- Previous receipt of any antibody treatment involving anti-PD-1, anti-PD-L1/L2, or anti-CTLA4 or other immunotherapies. Previous receipt of anti-VEGF and/or VEGFR, RAF, MEK, PDGFR, and FGFR targeted therapy.
- Pregnant or breastfeeding female patients.
- lead to the following consequences: increased study participation or drug-related risks, or interference with interpreting trial results, and considered ineligible for participating in the trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
About this study
Official title: Hepatic Arterial Infusion of Oxaliplatin Plus Fluorouracil/Leucovorin Combined With Cadonilimab and Bevacizumab as First-line Therapy in Unresectable Hepatocellular Carcinoma: a Single Center, Open Label, Single Arm,, Phase II Trial
To evaluate the efficacy and safety of HAIC combined with Cadonilimab and bevacizumab as first-line therapy in Unresectable hepatocellular carcinoma
Read the detailed description
An open label, single-arm, single center, phase II study evaluating HAIC combined with cadonilimab and bevacizumab as first-line therapy in unresectable hepatocellular carcinoma
- Conditions
- Unrescetable Hepatocellular Carcinoma
- Being tested
- HAIC+Cadonilimab+Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC+Cadonilimab+BevacizumabDrug
Cadonilimab: 10mg/kg, iv,q3w Bevacizumab: 7.5mg/kg, iv, q3w HAIC: Oxaliplatin plus Fluorouracil/Leucovorin
| Study group | Role | What they receive |
|---|---|---|
| HAIC+cadonilimab+bev | Experimental | Not described Receives: Drug: HAIC+Cadonilimab+Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate ( ORR) per RECIST 1.1
Defined as proportion of patients who have a best response of CR or PR
Measured: Up to 1 year
Secondary outcomes (4)
Overall survival (OS)
Defined as the time from enrollment to death from any cause
Measured: Up to two years
Progress Free Survival (PFS)
Defined as the time from enrollment to disease progression or death (whichever occurs first)
Measured: Up to two 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 two years
Disease Control Rate (DCR) per RECIST 1.1
Defined as proportion of patients who have CR or PR or SD
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrescetable Hepatocellular CarcinomaStudies 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
- Principal investigator, HuiKai Li, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821361
- Sponsor's protocol ID
- AK104-IIT-C-N-0052
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion of Oxaliplatin Plus Fluorouracil/Leucovorin Combined With Cadonilimab and Bevacizumab as First-line Therapy in Unresectable Hepatocellular Carcinoma: a Single Center, Open Label, Single Arm,, Phase II Trial
- ClinicalTrials.gov ID
- NCT05821361
- Acronym / sponsor ID
- AK104-IIT-C-N-0052
- Conditions
- Unrescetable Hepatocellular Carcinoma
- 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
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 20 Apr 2023 (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.
To evaluate the efficacy and safety of HAIC combined with Cadonilimab and bevacizumab as first-line therapy in Unresectable hepatocellular carcinoma
Detailed description
An open label, single-arm, single center, phase II study evaluating HAIC combined with cadonilimab and bevacizumab as first-line therapy in 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 |
|---|---|---|
| HAIC+cadonilimab+bev | Experimental | Drug: HAIC+Cadonilimab+Bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- written informed consent signed prior to enrolment.
- age 18-75 years, both sexes.
- Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by American Association for the Study of Liver Diseases (AASLD).
- ECOG PS of 0 or 1.
- Absence of systemic anti-tumor treatment for HCC before the first dose.
Key exclusion criteria (14 listed)
- Histologically/cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma.
- History of hepatic encephalopathy or liver transplantation.
- Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.
- Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA > 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA > 103 copies/mL; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive concurrently. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled.
- Presence of metastasis to the central nervous system.
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 |
|---|---|---|
| HAIC+Cadonilimab+BevacizumabCadonilimab: 10mg/kg, iv,q3w Bevacizumab: 7.5mg/kg, iv, q3w HAIC: Oxaliplatin plus Fluorouracil/Leucovorin | Drug | HAIC+cadonilimab+bev |
Primary outcome
Overall response rate ( ORR) per RECIST 1.1
Time frame: Up to 1 year
Defined as proportion of patients who have a best response of CR or PR
4 secondary outcomes
Overall survival (OS)
Time frame: Up to two years
Progress Free Survival (PFS)
Time frame: Up to two years
Adverse Events (AEs)
Time frame: Up to two years
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 HAIC+Cadonilimab+Bevacizumab in people with Unrescetable 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 13 inclusion and 14 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 20 Apr 2023. 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?
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?
Overall response rate ( ORR) per RECIST 1.1 (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 20 Apr 2023.