Hepato Cellular Carcinoma (HCC)Phase 2NCT06742424
PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC
A Phase 2 study testing PD-L1 antibody, Bevacizumab and HAIC-FOLFOX in people with Hepato Cellular Carcinoma (HCC), run by West China Hospital at 1 site in China.
Trial summary
This is a single-arm, phase II clinical trial evaluating the safety and efficacy of PD-L1 antibody combined with bevacizumab and hepatic arterial infusion chemotherapy (HAIC) for patients with advanced unresectable hepatocellular carcinoma (HCC) with extrahepatic metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepato Cellular Carcinoma (HCC)
- What is being tested?
- PD-L1 antibody, Bevacizumab and HAIC-FOLFOX
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Histologically/cytologically confirmed hepatocellular carcinoma (HCC) or clinically diagnosed according to HCC diagnostic criteria Radiologically confirmed extrahepatic metastases with unresectable disease as evaluated by investigators No prior treatment with PD-L1 antibody and/or bevacizumab Age ≥18 and ≤75 years ECOG Performance Status 0-1 Child-Pugh Class A or B7 Able to comply with study protocol requirements At least one measurable or evaluable lesion according to RECIST v1.1
- Adequate organ and bone marrow function:
- Absolute neutrophil count ≥1.5×10^9/L Platelet count ≥75×10^9/L Hemoglobin ≥9.0 g/dL Total bilirubin ≤2×ULN ALT and AST ≤5×ULN Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min Urine protein <2+ by dipstick APTT and INR ≤1.5×ULN Normal cardiac enzymes Normal thyroid function or on stable replacement therapy Life expectancy ≥12 weeks Effective contraception for participants of childbearing potential during treatment and for 6 months after last dose
Who cannot join
- Severe complications from liver disease (severe bleeding from portal hypertension, infection, hepatic encephalopathy) Prior systemic anti-tumor therapy for HCC Other malignancy within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ) Current participation in other interventional clinical trials Systemic treatment with Chinese herbal medicine or immunomodulators within 2 weeks before first dose Active autoimmune disease requiring systemic treatment within 2 years Systemic corticosteroid therapy within 7 days before first dose Prior allogeneic organ transplantation (except corneal) or stem cell transplantation Known allergy to monoclonal antibodies or HAIC components Inadequate recovery from prior treatment toxicities Known HIV infection Untreated active HBV infection (HBsAg positive with HBV-DNA above upper limit of normal) Active HCV infection Live vaccine administration within 30 days before first dose Pregnancy or breastfeeding
- Serious or uncontrolled systemic diseases including:
- Significant cardiac arrhythmias or conduction abnormalities Unstable angina or NYHA class ≥2 heart failure Arterial thrombotic events within 6 months Uncontrolled hypertension Active interstitial lung disease Active tuberculosis Active systemic infections Active diverticulitis or GI obstruction Uncontrolled diabetes Significant proteinuria Psychiatric disorders affecting compliance Any condition that could interfere with study participation or interpretation of results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Yiwen Qiu, M.D., +8613281003787, qyw@wchscu.edu.cn
About this study
Official title: Efficacy and Safety of PD-L1 Antibody Combined With Bevacizumab and Hepatic Arterial Infusion Chemotherapy in Advanced Unresectable Hepatocellular Carcinoma With Extrahepatic Metastases: A Single-Arm, Prospective, Phase II Clinical Study
This is a single-arm, phase II clinical trial evaluating the safety and efficacy of PD-L1 antibody combined with bevacizumab and hepatic arterial infusion chemotherapy (HAIC) for patients with advanced unresectable hepatocellular carcinoma (HCC) with extrahepatic metastases.
Study Population: Patients with advanced HCC who have:
Read more
- Confirmed extrahepatic metastases
- No prior PD-L1 or bevacizumab therapy
- Age 18-75 years
- Child-Pugh A or B7 liver function
- ECOG performance status 0-1
Treatment Regimen:
- PD-L1 antibody: 1200mg every 3 weeks
- Bevacizumab: 15mg/kg every 3 weeks
- HAIC with FOLFOX regimen: Up to 6 cycles
- Treatment continues until disease progression or up to 24 months
Primary Endpoint:
-Objective Response Rate (ORR)
Secondary Endpoints:
- Disease Control Rate (DCR)
- Duration of Response (DOR)
- Progression-free Survival (PFS)
- Overall Survival (OS)
- Safety assessments
- Quality of life measurements
Study Design Details:
- Single-arm study using Simon's two-stage design
- First stage: 27 patients
- Second stage: 9 additional patients if first stage shows efficacy
- Total planned enrollment: 36 patients
- Study duration: October 2024 - July 2027
This study aims to evaluate whether adding HAIC to PD-L1 inhibitor plus bevacizumab immunotherapy can improve outcomes for advanced HCC patients with extrahepatic spread, who currently have limited treatment options. The trial will assess both efficacy and safety of this combination approach.
- Conditions
- Hepato Cellular Carcinoma (HCC)
- Being tested
- PD-L1 antibody, Bevacizumab, HAIC-FOLFOX
- Keywords
- HAIC, PD-L1, Bevacizumab, extrahepatic metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L1 antibodyDrug
1200mg intravenously every 3 weeks
BevacizumabDrug
15mg/kg intravenously every 3 weeks
HAIC-FOLFOXProcedure or surgery
Oxaliplatin 130 mg/m² via hepatic arterial infusion over 3 hours Leucovorin 400 mg/m² via hepatic arterial infusion over 2 hours Fluorouracil 400 mg/m² bolus via hepatic arterial infusion at hour 5, followed by 2400 mg/m² continuous hepatic arterial infusion over 46 hours HAIC treatment repeats every 3 weeks for up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| PD-L1 Antibody + Bevacizumab + HAIC-FOLFOX | Experimental | Participants will receive:
* PD-L1 antibody 1200mg intravenously every 3 weeks
* Bevacizumab 15mg/kg intravenously every 3 weeks
* HAIC-FOLFOX regimen (up to 6 cycles) consisting of:
* Oxaliplatin 130 mg/m² via hepatic arterial infusion over 3 hours
* Leucovorin 400 mg/m² via hepatic arterial infusion over 2 hours
* Fluorouracil 400 mg/m² bolus via hepatic arterial infusion at hour 5, followed by 2400 mg/m² continuous hepatic arterial infusion over 46 hours
* HAIC treatment repeats every 3 weeks for up to 6 cycles After completion of HAIC, participants will continue to receive PD-L1 antibody and bevacizumab until disease progression, unacceptable toxicity, or up to 24 months of treatment. Tumor assessments will be performed every 9 weeks for the first 48 weeks, then every 12 weeks thereafter. Receives: Drug: PD-L1 antibody; Drug: Bevacizumab; Procedure: HAIC-FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) as Assessed by RECIST v1.1
Measured: From first dose until disease progression or up to 24 months of treatment, with tumor assessments performed every 9 weeks for the first 48 weeks and every 12 weeks thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Oct 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by West China 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wentao Wang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742424
- Sponsor's protocol ID
- 2024(2134)
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PD-L1 Antibody Combined With Bevacizumab and Hepatic Arterial Infusion Chemotherapy in Advanced Unresectable Hepatocellular Carcinoma With Extrahepatic Metastases: A Single-Arm, Prospective, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06742424
- Acronym / sponsor ID
- 2024(2134)
- Conditions
- Hepato Cellular Carcinoma (HCC)
- Keywords
- HAIC, PD-L1, Bevacizumab, extrahepatic metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 19 Dec 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 is a single-arm, phase II clinical trial evaluating the safety and efficacy of PD-L1 antibody combined with bevacizumab and hepatic arterial infusion chemotherapy (HAIC) for patients with advanced unresectable hepatocellular carcinoma (HCC) with extrahepatic metastases.
Study Population: Patients with advanced HCC who have:
- Confirmed extrahepatic metastases
- No prior PD-L1 or bevacizumab therapy
- Age 18-75 years
- Child-Pugh A or B7 liver function
- ECOG performance status 0-1
Treatment Regimen:
- PD-L1 antibody: 1200mg every 3 weeks
- Bevacizumab: 15mg/kg every 3 weeks
- HAIC with FOLFOX regimen: Up to 6 cycles
- Treatment continues until disease progression or up to 24 months
Primary Endpoint:
-Objective Response Rate (ORR)
Secondary Endpoints:
- Disease Control Rate (DCR)
- Duration of Response (DOR)
- Progression-free Survival (PFS)
- Overall Survival (OS)
- Safety assessments
- Quality of life measurements
Study Design Details:
- Single-arm study using Simon's two-stage design
- First stage: 27 patients
- Second stage: 9 additional patients if first stage shows efficacy
- Total planned enrollment: 36 patients
- Study duration: October 2024 - July 2027
This study aims to evaluate whether adding HAIC to PD-L1 inhibitor plus bevacizumab immunotherapy can improve outcomes for advanced HCC patients with extrahepatic spread, who currently have limited treatment options. The trial will assess both efficacy and safety of this combination approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-L1 Antibody + Bevacizumab + HAIC-FOLFOX | Experimental | Drug: PD-L1 antibody, Drug: Bevacizumab, Procedure: HAIC-FOLFOXParticipants will receive: * PD-L1 antibody 1200mg intravenously every 3 weeks * Bevacizumab 15mg/kg intravenously every 3 weeks * HAIC-FOLFOX regimen (up to 6 cycles) consisting of: * Oxaliplatin 130 mg/m² via hepatic arterial infusion over 3 hours * Leucovorin 400 mg/m² via hepatic arterial infusion over 2 hours * Fluorouracil 400 mg/m² bolus via hepatic arterial infusion at hour 5, followed by 2400 mg/m² continuous hepatic arterial infusion over 46 hours * HAIC treatment repeats every 3 weeks for up to 6 cycles After completion of HAIC, participants will continue to receive PD-L1 antibody and bevacizumab until disease progression, unacceptable toxicity, or up to 24 months of treatment. Tumor assessments will be performed every 9 weeks for the first 48 weeks, then every 12 weeks thereafter. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed written informed consent Histologically/cytologically confirmed hepatocellular carcinoma (HCC) or clinically diagnosed according to HCC diagnostic criteria Radiologically confirmed extrahepatic metastases with unresectable disease as evaluated by investigators No prior treatment with PD-L1 antibody and/or bevacizumab Age ≥18 and ≤75 years ECOG Performance Status 0-1 Child-Pugh Class A or B7 Able to comply with study protocol requirements At least one measurable or evaluable lesion according to RECIST v1.1
- Absolute neutrophil count ≥1.5×10^9/L Platelet count ≥75×10^9/L Hemoglobin ≥9.0 g/dL Total bilirubin ≤2×ULN ALT and AST ≤5×ULN Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min Urine protein <2+ by dipstick APTT and INR ≤1.5×ULN Normal cardiac enzymes Normal thyroid function or on stable replacement therapy Life expectancy ≥12 weeks Effective contraception for participants of childbearing potential during treatment and for 6 months after last dose
Key exclusion criteria (3 listed)
- Severe complications from liver disease (severe bleeding from portal hypertension, infection, hepatic encephalopathy) Prior systemic anti-tumor therapy for HCC Other malignancy within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ) Current participation in other interventional clinical trials Systemic treatment with Chinese herbal medicine or immunomodulators within 2 weeks before first dose Active autoimmune disease requiring systemic treatment within 2 years Systemic corticosteroid therapy within 7 days before first dose Prior allogeneic organ transplantation (except corneal) or stem cell transplantation Known allergy to monoclonal antibodies or HAIC components Inadequate recovery from prior treatment toxicities Known HIV infection Untreated active HBV infection (HBsAg positive with HBV-DNA above upper limit of normal) Active HCV infection Live vaccine administration within 30 days before first dose Pregnancy or breastfeeding
- Significant cardiac arrhythmias or conduction abnormalities Unstable angina or NYHA class ≥2 heart failure Arterial thrombotic events within 6 months Uncontrolled hypertension Active interstitial lung disease Active tuberculosis Active systemic infections Active diverticulitis or GI obstruction Uncontrolled diabetes Significant proteinuria Psychiatric disorders affecting compliance Any condition that could interfere with study participation or interpretation of results
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 |
|---|---|---|
| PD-L1 antibody1200mg intravenously every 3 weeks | Drug | PD-L1 Antibody + Bevacizumab + HAIC-FOLFOX |
| Bevacizumab15mg/kg intravenously every 3 weeks | Drug | PD-L1 Antibody + Bevacizumab + HAIC-FOLFOX |
| HAIC-FOLFOXOxaliplatin 130 mg/m² via hepatic arterial infusion over 3 hours Leucovorin 400 mg/m² via hepatic arterial infusion over 2 hours Fluorouracil 400 mg/m² bolus via hepatic arterial infusion at hour 5, followed by 2400 mg/m² continuous hepatic arterial infusion over 46 hours HAIC treatment repeats every 3 weeks for up to 6 cycles | Procedure or surgery | PD-L1 Antibody + Bevacizumab + HAIC-FOLFOX |
Primary outcome
Objective Response Rate (ORR) as Assessed by RECIST v1.1
Time frame: From first dose until disease progression or up to 24 months of treatment, with tumor assessments performed every 9 weeks for the first 48 weeks and every 12 weeks thereafter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 PD-L1 antibody, Bevacizumab and HAIC-FOLFOX in people with Hepato Cellular Carcinoma (HCC), run by West China 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiwen Qiu, M.D. (+8613281003787, qyw@wchscu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) as Assessed by RECIST v1.1 (time frame: From first dose until disease progression or up to 24 months of treatment, with tumor assessments performed every 9 weeks for the first 48 weeks and every 12 weeks thereafter.). 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 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.