Adebrelimab (SHR-1316)Phase 2NCT07543783
Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by Hepatic Arterial Infusion Chemotherapy (TACE-HAIC) as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Phase 2 Trial
A Phase 2 study testing Transarterial Chemoembolization (TACE), Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX) and Adebrelimab in people with Adebrelimab (SHR-1316) and Bevacizumab, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
his is a single-arm, phase II clinical study evaluating the efficacy and safety of low-dose bevacizumab (7.5 mg/kg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen as first-line treatment for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adebrelimab (SHR-1316), Bevacizumab, Hepatocellular Carcinoma (HCC)
- What is being tested?
- Transarterial Chemoembolization (TACE), Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX) and Adebrelimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 31 Aug 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate and provide written informed consent. Age ≥ 18 years (on the day of signing informed consent). Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinical diagnosis of HCC according to AASLD criteria in patients with cirrhosis.
- Eligible for TACE, including BCLC stage B or C, with unresectable HCC (excluding PVTT-Vp4 and extrahepatic metastasis).
- No prior systemic therapy for HCC. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Child-Pugh score A or B7. No history of autoimmune disease. Life expectancy ≥ 3 months. At least one measurable lesion per RECIST v1.1 (spiral CT scan long diameter ≥ 10 mm or short diameter of enlarged lymph node ≥ 15 mm; lesions previously treated with locoregional therapy can be considered target lesions only if progression per RECIST v1.1 is clearly documented).
- Adequate hematologic, hepatic, and renal function within 7 days prior to enrollment:
- Neutrophils ≥ 1.5 × 10⁹/L Platelets ≥ 50 × 10⁹/L Hemoglobin ≥ 90 g/L ALT/AST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN INR < 2.3 or prothrombin time ≤ ULN + 6 seconds Albumin ≥ 30 g/L Total bilirubin ≤ 3 × ULN Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be lactating; they and male participants must agree to use effective contraception during the study and for 6 months after study completion
Who cannot join
- Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years, excluding cured localized tumors such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ.
- Severe allergy to iodine contrast precluding TACE-HAIC. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment.
- Active uncontrolled infection. Severe gastroesophageal varices; untreated or incompletely treated varices (with bleeding or high bleeding risk).
- Brain metastases or bone metastases requiring urgent surgical or radiation intervention.
- Pregnant, suspected pregnancy, or breastfeeding. Current or recent use (within 10 days prior to study treatment) of aspirin (> 325 mg/day) or dipyridamole, ticlopidine, clopidogrel, or cilostazol.
- Thromboembolic events within 6 months prior to study treatment, including cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
- Congenital or acquired immunodeficiency. Myocardial infarction, severe/unstable angina, or congestive heart failure within 12 months prior to study start.
- Renal insufficiency requiring dialysis. History of organ transplantation. Any other serious acute or chronic medical or psychiatric condition, or laboratory abnormality that would increase the risk of study participation or interfere with interpretation of results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
his is a single-arm, phase II clinical study evaluating the efficacy and safety of low-dose bevacizumab (7.5 mg/kg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Eligible participants will receive TACE followed by HAIC (oxaliplatin, leucovorin, and fluorouracil) and subsequent intravenous administration of adebrelimab and low-dose bevacizumab every 3 weeks. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. A total of 38 participants will be enrolled using Simon's two-stage optimal design (alpha=0.05, power=0.8). The study is sponsored by the Third Affiliated Hospital of Sun Yat-sen University. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd.
- Being tested
- Transarterial Chemoembolization (TACE), Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX), Adebrelimab, Low-dose Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial Chemoembolization (TACE)Procedure or surgery
Transarterial chemoembolization performed as first-line intervention for unresectable hepatocellular carcinoma.
Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX)Drug
Hepatic arterial infusion chemotherapy with FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² continuous infusion over 24 hours).
AdebrelimabDrug
Intravenous adebrelimab 1200 mg fixed dose, administered every 3 weeks (Q3W).
Low-dose BevacizumabDrug
Intravenous bevacizumab 7.5 mg/kg, administered every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| TACE-HAIC + Adebrelimab + Low-dose Bevacizumab | Experimental | Participants with unresectable hepatocellular carcinoma (HCC) receive first-line treatment with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² continuous infusion over 24 hours), administered via hepatic artery catheter. Subsequently, participants receive intravenous adebrelimab (1200 mg fixed dose, Q3W) and low-dose bevacizumab (7.5 mg/kg, Q3W). Each treatment cycle is 21 days. Treatment continues until disease progression (RECIST v1.1), unacceptable toxicity, patient withdrawal, conversion to resectable disease, or investigator decision. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd. Receives: Procedure: Transarterial Chemoembolization (TACE); Drug: Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX); Drug: Adebrelimab; Drug: Low-dose Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of participants achieving complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST v1.1 criteria, assessed by the investigator.
Measured: Up to 36 months from the first dose of study treatment
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 criteria or death from any cause, whichever occurs first, as assessed by the investigator.
Measured: From the first dose of study treatment until disease progression or death, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adebrelimab (SHR-1316)Studies of the same condition, open and under way.
- 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Huang Mingsheng, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543783
- Sponsor's protocol ID
- II2026-037-02
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 28 Apr 2026
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by Hepatic Arterial Infusion Chemotherapy (TACE-HAIC) as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07543783
- Acronym / sponsor ID
- II2026-037-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 22 Apr 2026 (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.
his is a single-arm, phase II clinical study evaluating the efficacy and safety of low-dose bevacizumab (7.5 mg/kg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Eligible participants will receive TACE followed by HAIC (oxaliplatin, leucovorin, and fluorouracil) and subsequent intravenous administration of adebrelimab and low-dose bevacizumab every 3 weeks. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. A total of 38 participants will be enrolled using Simon's two-stage optimal design (alpha=0.05, power=0.8). The study is sponsored by the Third Affiliated Hospital of Sun Yat-sen University. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE-HAIC + Adebrelimab + Low-dose Bevacizumab | Experimental | Procedure: Transarterial Chemoembolization (TACE), Drug: Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX), Drug: Adebrelimab, Drug: Low-dose BevacizumabParticipants with unresectable hepatocellular carcinoma (HCC) receive first-line treatment with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² continuous infusion over 24 hours), administered via hepatic artery catheter. Subsequently, participants receive intravenous adebrelimab (1200 mg fixed dose, Q3W) and low-dose bevacizumab (7.5 mg/kg, Q3W). Each treatment cycle is 21 days. Treatment continues until disease progression (RECIST v1.1), unacceptable toxicity, patient withdrawal, conversion to resectable disease, or investigator decision. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to participate and provide written informed consent. Age ≥ 18 years (on the day of signing informed consent). Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinical diagnosis of HCC according to AASLD criteria in patients with cirrhosis.
- Eligible for TACE, including BCLC stage B or C, with unresectable HCC (excluding PVTT-Vp4 and extrahepatic metastasis).
- No prior systemic therapy for HCC. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Child-Pugh score A or B7. No history of autoimmune disease. Life expectancy ≥ 3 months. At least one measurable lesion per RECIST v1.1 (spiral CT scan long diameter ≥ 10 mm or short diameter of enlarged lymph node ≥ 15 mm; lesions previously treated with locoregional therapy can be considered target lesions only if progression per RECIST v1.1 is clearly documented).
- Neutrophils ≥ 1.5 × 10⁹/L Platelets ≥ 50 × 10⁹/L Hemoglobin ≥ 90 g/L ALT/AST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN INR < 2.3 or prothrombin time ≤ ULN + 6 seconds Albumin ≥ 30 g/L Total bilirubin ≤ 3 × ULN Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be lactating; they and male participants must agree to use effective contraception during the study and for 6 months after study completion
Key exclusion criteria (8 listed)
- Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years, excluding cured localized tumors such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ.
- Severe allergy to iodine contrast precluding TACE-HAIC. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment.
- Active uncontrolled infection. Severe gastroesophageal varices; untreated or incompletely treated varices (with bleeding or high bleeding risk).
- Brain metastases or bone metastases requiring urgent surgical or radiation intervention.
- Pregnant, suspected pregnancy, or breastfeeding. Current or recent use (within 10 days prior to study treatment) of aspirin (> 325 mg/day) or dipyridamole, ticlopidine, clopidogrel, or cilostazol.
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 |
|---|---|---|
| Transarterial Chemoembolization (TACE)Transarterial chemoembolization performed as first-line intervention for unresectable hepatocellular carcinoma. | Procedure or surgery | TACE-HAIC + Adebrelimab + Low-dose Bevacizumab |
| Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX)Hepatic arterial infusion chemotherapy with FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² continuous infusion over 24 hours). | Drug | TACE-HAIC + Adebrelimab + Low-dose Bevacizumab |
| AdebrelimabIntravenous adebrelimab 1200 mg fixed dose, administered every 3 weeks (Q3W). | Drug | TACE-HAIC + Adebrelimab + Low-dose Bevacizumab |
| Low-dose BevacizumabIntravenous bevacizumab 7.5 mg/kg, administered every 3 weeks (Q3W). | Drug | TACE-HAIC + Adebrelimab + Low-dose Bevacizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 36 months from the first dose of study treatment
Percentage of participants achieving complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST v1.1 criteria, assessed by the investigator.
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until disease progression or death, up to 36 months
PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 criteria or death from any cause, whichever occurs first, as assessed by the investigator.
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 28 Apr 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transarterial Chemoembolization (TACE), Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX) and Adebrelimab in people with Adebrelimab (SHR-1316) and Bevacizumab, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 5 inclusion and 8 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 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mingsheng Huang (+86-20-85253416, huangmsh@mail.sysu.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) (time frame: Up to 36 months from the first dose of study treatment). The study lists 2 primary outcomes in all. 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 28 Apr 2026.