Unresectable Hepatocellular CarcinomaNCT07045558
HAIC + Atezolizumab Plus Bevacizumab in Unresectable HCC
An observational study of Unresectable Hepatocellular Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
Patients with unresectable HCC will be enrolled in the cohort and will receive the combination therapy of HAIC and atezolizumab plus bevacizumab. The objective response rate is the primary endpoint, and the secondary endpoint includes disease control rate, conversion rate, pathologic complete response, major… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Jan 2028
- Phase
- Observational
- 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
Study population: Patients who is diagnosed as unresectable hepatocellular carcinoma (BCLC stage B/C) histologically , cytologically, or clinically.
Who may be able to join
- Patients between 18 and 75 years old, with no gender restrictions.
- Confirmed unresectable hepatocellular carcinoma (BCLC stage B/C) by histology, cytology, or clinical diagnosis.
- At least one measurable lesion based on RECIST version 1.1.
- Child-Pugh class A or B7.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- No prior systemic therapy received, with an expected survival ≥12 weeks.
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- Adequate organ function meeting the following criteria:
- Hematological parameters (without blood transfusion within 14 days): Hemoglobin (Hb) ≥80 g/L, White blood cell count (WBC) ≥3 × 10⁹/L, Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, Platelet count (PLT) ≥50 × 10⁹/L; B. Biochemical parameters: Total bilirubin (TBIL) <1.5 × upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 × ULN, Serum creatinine (Cr) ≤1.5 × ULN.
- Contraception requirements: Women of childbearing age must have a negative serum or urine pregnancy test (HCG) within 7 days before enrollment and agree to use effective contraceptive methods during the trial period and for 8 weeks after the last dose. Men must either have undergone surgical sterilization or agree to use appropriate contraceptive methods during the trial period and for 8 weeks after the last dose.
- Willingness to voluntarily participate in the study, with good compliance and commitment to follow-up.
Who cannot join
- Known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, sarcomatoid HCC, or fibrolamellar carcinoma.
- Concurrent autoimmune diseases, organ/hematopoietic stem cell transplantation history, or other malignancies.
- Impaired consciousness, inability to cooperate with treatment, or active psychiatric disorders.
- Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), bevacizumab, molecular targeted therapy, atezolizumab, or other PD-1/PD-L1 inhibitors received before enrollment.
- Major surgery, chemotherapy, radiotherapy, or systemic therapy for lesions received within 1 month before enrollment.
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (>10 mg/day prednisone or other equivalent drugs) within 14 days before enrollment.
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- Severe esophageal varices or high risk of bleeding assessed by endoscopy.
- Evidence of decompensated liver function, including ascites, gastrointestinal bleeding, or hepatic encephalopathy.
- Severe organ dysfunction in major organs such as the liver, kidneys, heart, lungs, or brain.
- Other contraindications for interventional therapy, molecular targeted therapy, or immunotherapy.
- Inability to undergo scheduled follow-up or concurrent participation in other clinical trials that may interfere with this study.
- Other severe comorbidities deemed by the investigator to jeopardize patient safety or compromise study completion.
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
Renji Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai
About this study
Official title: HAIC in Combination With Atezolizumab Plus Bevacizumab as Conversion Therapy in Unresectable Hepatocellular Carcinoma: a Single-arm, Prospective Study
Patients with unresectable HCC will be enrolled in the cohort and will receive the combination therapy of HAIC and atezolizumab plus bevacizumab. The objective response rate is the primary endpoint, and the secondary endpoint includes disease control rate, conversion rate, pathologic complete response, major pathologic response, progression-free survival, recurrence-free survival, overall survival, quality of life, and safety.
- Conditions
- Unresectable Hepatocellular Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental cohort | The experimental cohort is going to enroll unrescetable HCC patients, and they will receive HAIC in combination with atezolizumab plus bevacizumab as conversion therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Complete response (CR) and partial response (PR), refer to cases evaluated by the mRECIST criteria for objective tumor response, including both CR and PR.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045558
- Sponsor's protocol ID
- LY2025-039-C
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAIC in Combination With Atezolizumab Plus Bevacizumab as Conversion Therapy in Unresectable Hepatocellular Carcinoma: a Single-arm, Prospective Study
- ClinicalTrials.gov ID
- NCT07045558
- Acronym / sponsor ID
- LY2025-039-C
- Conditions
- Unresectable Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 1 Jul 2025 (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.
Patients with unresectable HCC will be enrolled in the cohort and will receive the combination therapy of HAIC and atezolizumab plus bevacizumab. The objective response rate is the primary endpoint, and the secondary endpoint includes disease control rate, conversion rate, pathologic complete response, major pathologic response, progression-free survival, recurrence-free survival, overall survival, quality of life, and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental cohort | – | –The experimental cohort is going to enroll unrescetable HCC patients, and they will receive HAIC in combination with atezolizumab plus bevacizumab as conversion therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who is diagnosed as unresectable hepatocellular carcinoma (BCLC stage B/C) histologically , cytologically, or clinically.
Key inclusion criteria (10 listed)
- Patients between 18 and 75 years old, with no gender restrictions.
- Confirmed unresectable hepatocellular carcinoma (BCLC stage B/C) by histology, cytology, or clinical diagnosis.
- At least one measurable lesion based on RECIST version 1.1.
- Child-Pugh class A or B7.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Key exclusion criteria (12 listed)
- Known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, sarcomatoid HCC, or fibrolamellar carcinoma.
- Concurrent autoimmune diseases, organ/hematopoietic stem cell transplantation history, or other malignancies.
- Impaired consciousness, inability to cooperate with treatment, or active psychiatric disorders.
- Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), bevacizumab, molecular targeted therapy, atezolizumab, or other PD-1/PD-L1 inhibitors received before enrollment.
- Major surgery, chemotherapy, radiotherapy, or systemic therapy for lesions received within 1 month before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective Response Rate
Time frame: 2 years
Complete response (CR) and partial response (PR), refer to cases evaluated by the mRECIST criteria for objective tumor response, including both CR and PR.
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 1 Jul 2025.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Unresectable Hepatocellular Carcinoma, run by RenJi 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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 1 Jul 2025. 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.
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 Chengpeng Zhong (+86 18801900435, deriszhong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 2 years). 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 1 Jul 2025.