Hepatocellular Carcinoma (HCC)Phase 2/3NCT07490262
A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.
A Phase 2/3 study testing Bevacizumab, Capecitabine and Oxaliplatin in people with Hepatocellular Carcinoma (HCC), run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. at 2 sites in China.
Trial summary
This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Bevacizumab, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 2 sitesChina
- Study dates
- 27 Mar 2026to 31 Dec 2030
- Phase
- Phase 2/3
- 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
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuitable for curative-intent surgery and/or locoregional therapy.
- No prior systemic antineoplastic therapy for HCC before first dose.
- At screening, per RECIST 1.1, there must be at least one measurable lesion that has not undergone local therapy, or a measurable lesion that has clearly progressed following local therapy (per RECIST 1.1).
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- Child-Pugh score ≤7.
- Adequate organ and bone marrow function.
- Expected survival ≥12 weeks at the time of treatment initiation.
- Female participants of childbearing potential, or male participants whose sexual partners are of childbearing potential, must use effective contraception throughout the treatment period and for 15 months after the last dose of oxaliplatin (for females) / 12 months after the last dose of oxaliplatin (for males), or for 6 months after the last dose of any other investigational drug-whichever period ends later.
- Signed written informed consent form, and ability to comply with scheduled visits and all protocol-specified procedures.
Who cannot join
- Histologically or cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, or other mixed hepatic malignancies containing these components.
- History of hepatic encephalopathy or prior liver transplantation.
- Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring therapeutic drainage; participants with only minimal (radiologically detected), asymptomatic effusions may be enrolled.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection:
- Known central nervous system (CNS) metastases or symptomatic spinal cord compression.
- Esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months; Grade 3 (G3) esophageal/gastric varices documented by endoscopy within 3 months prior to first dose; or evidence of portal hypertension.
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- Life-threatening hemorrhagic event within the past 3 months, including but not limited to events requiring blood transfusion, surgical or local intervention, or ongoing pharmacologic hemostatic therapy.
- Metastatic lesions invading major vessels, airways, or the mediastinum with clinically significant bleeding risk.
- Arterial or venous thromboembolic event within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident (stroke), transient ischemic attack (TIA), pulmonary embolism, deep vein thrombosis, or other severe thromboembolic conditions.
- Portal vein tumor thrombus (PVTT) involving both the main portal vein and left/right branch; PVTT extending into the superior mesenteric vein; or PVTT involving the inferior vena cava.
- Use of aspirin (>325 mg/day) or other known platelet-function-inhibiting agents (e.g., dipyridamole or clopidogrel) for therapeutic purposes within 10 days prior to randomization. Prophylactic use of anticoagulants is permitted.
- Uncontrolled hypertension: systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg despite optimal medical management; history of hypertensive crisis or hypertensive encephalopathy.
- Persistent treatment-related toxicities from prior anticancer therapy not resolved to Grade 0 or Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 at the time of randomization.
- Symptomatic congestive heart failure (New York Heart Association [NYHA] Class II-IV); symptomatic or inadequately controlled arrhythmias; history of congenital long QT syndrome; or baseline corrected QT interval (QTcF, calculated using Fridericia's formula) >500 ms.
- Severe bleeding diathesis or coagulopathy; or current thrombolytic therapy.
- History of gastrointestinal perforation and/or fistula within the past 6 months; unresolved intestinal obstruction (including incomplete obstruction requiring parenteral nutrition); extensive bowel resection (e.g., partial colectomy or extensive small bowel resection leading to chronic diarrhea); Crohn's disease; ulcerative colitis; or chronic diarrhea of prolonged duration.
- Prior radiotherapy within 3 weeks before randomization.
- Clinically significant pre-existing pulmonary disease.
- Active tuberculosis (TB), currently receiving anti-TB therapy, or having completed anti-TB therapy within the past year.
- Known human immunodeficiency virus (HIV) infection (positive HIV-1/2 antibody test).
- Active or inadequately controlled severe infection.
- Known or suspected active autoimmune disease, or history of active autoimmune disease within the past 2 years.
- Systemic immunosuppressive therapy within 2 weeks prior to randomization.
- Receipt of live attenuated vaccines within 4 weeks prior to randomization, or planned administration during the study.
- Major surgery (e.g., craniotomy, thoracotomy, laparotomy) or presence of unhealed wounds, ulcers, or fractures within 4 weeks prior to randomization.
- Local therapy for HCC within 4 weeks prior to first dose.
- Use of Traditional Chinese Medicine (TCM) with antitumor indications, or immunomodulatory agents (e.g., thymosin, interferons, interleukins), within 2 weeks prior to first dose.
- Uncontrolled or uncorrectable metabolic disorders, non-malignant organ dysfunction, systemic illness, or cancer-related paraneoplastic syndromes posing substantial medical risk or introducing uncertainty in survival assessment - as determined by the investigator; or any other condition deemed unsuitable for enrollment by the investigator.
- Diagnosis of another primary malignancy within 5 years prior to randomization.
- Prior treatment with any anti-PD-1, anti-PD-L1/L2, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors.
- Known hypersensitivity to any active ingredient or excipient of the investigational product; or history of severe allergic reaction (e.g., anaphylaxis) to other monoclonal antibodies.
- Receipt of treatment in another interventional clinical trial within 4 weeks prior to randomization.
- Female participants who are pregnant or breastfeeding.
- Any other acute or chronic medical condition, psychiatric disorder, or clinically significant laboratory abnormality that, in the Investigator's judgment: increases the risks associated with participation in the study or administration of the investigational product; or may interfere with the interpretation of study results - rendering the participant unsuitable for enrollment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hosptial of USTC
Hefei, Anhui, 230001
Lianxin Liu, 0551-62283477, liulx@ustc.edu.cn
- Not yet recruiting
Zhongshan Hospital, Fudan university
Shanghai, Shanghai Municipality, 200032
Jia Fan, PhD, 021-64041990, fan.jia@zs-hospital.sh.cn
About this study
Official title: A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy as First-line Treatment in Previously Untreated Patients With Unresectable or Metastatic Hepatocellular Carcinoma
This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Bevacizumab, Capecitabine, Oxaliplatin, IBI310, Sintilimab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabBiological
15 mg/kg intravenous infusion, administered on Day 1 of each 3-week treatment cycle
CapecitabineDrug
1000 mg/m² orally, administered on Days 1-14 of each 3-week treatment cycle, maximum 4 cycles.
OxaliplatinDrug
85 mg/m² intravenous infusion, administered on Day 1 of each 3-week treatment cycle, maximum 4 cycles.
IBI310Biological
1 mg/kg intravenous infusion, administered on Day 1 of each 6-week treatment cycle
SintilimabBiological
200 mg intravenous infusion, administered on Day 1 of each 3-week treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Sintilimab+ Bevacizumab Receives: Biological: Bevacizumab; Biological: Sintilimab |
| Treatment Group2 | Experimental | Sintilimab+ IBI310+Bevacizumab Receives: Biological: Bevacizumab; Biological: IBI310; Biological: Sintilimab |
| Treatment Group3 | Experimental | Sintilimab+ IBI310+Oxaliplatin+Capecitabine Receives: Drug: Capecitabine; Drug: Oxaliplatin; Biological: IBI310; Biological: Sintilimab |
| Treatment Group1 | Experimental | Sintilimab+ IBI310+Bevacizumab+Oxaliplatin+Capecitabine Receives: Biological: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin; Biological: IBI310; Biological: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: ORR （Objective Response Rate） assessed by investigator per RECIST 1.1.
Measured: up to 2 years
Phase II: PFS（Progression-Free Survival） assessed by investigator per RECIST 1.1.
Measured: up to 2 years
Phase II: AEs（Adverse Event）
Measured: up to 2 years
Phase II: TRAES（Treatment Emergent Adverse Event）
Measured: up to 2 years
Phase II: SAEs（Serious Adverse Event）
Measured: up to 2 years
Phase III: OS（Overall Survival）
Measured: up to 2 years
Phase III: PFS（Progression-Free Survival）assessed by the Independent Radiologic Review Committee (IRRC) per RECIST 1.1.
Measured: up to 2 years
Secondary outcomes (36)
Phase II: OS
Measured: up to 2 years
Phase II: Incidence and characteristics of ADA&Nab.
Measured: up to 2 years
Phase II: DoR (Duration of Response )
Measured: up to 2 years
Phase II: DCR (Disease Control Rate )
Measured: up to 2 years
Phase II: TTR (Time to Response )
Measured: up to 2 years
Phase II:Cmax (maximum plasma concentration)
One of the Pharmacokinetics parameters
Measured: up to 2 years
Phase II:Tmax (time to reach maximum concentration)
One of the Pharmacokinetics parameters
Measured: up to 2 years
Phase II: AUC (time curve)
One of the Pharmacokinetics parameters
Measured: up to 2 years
PhaseIII: ORR （Objective Response Rate）assessed by IRRC according to RECIST1.1.
Measured: up to 2 years
PhaseIII: DoR （Duration of Response）assessed by IRRC according to RECIST1.1.
Measured: up to 2 years
PhaseIII: DCR （Time to Response）assessed by IRRC according to RECIST1.1.
Measured: up to 2 years
PhaseIII: TTR（Time to Response） assessed by IRRC according to RECIST1.1.
Measured: up to 2 years
PhaseIII: ORR （Objective Response Rate）assessed by the investigator according to RECIST1.1.
Measured: up to 2 years
PhaseIII: PFS （Progression-Free Survival）assessed by the investigator according to RECIST1.1.
Measured: up to 2 years
PhaseIII: DoR （Duration of Response）assessed by the investigator according to RECIST1.1.
Measured: up to 2 years
PhaseIII: DCR（Time to Response） assessed by the investigator according to RECIST1.1.
Measured: up to 2 years
PhaseIII: TTR (Time to Response) assessed by the investigator according to RECIST1.1.
Measured: up to 2 years
Phase III: ORR （Objective Response Rate）assessed by IRRC according to mRECIST.
Measured: up to 2 years
Phase III: PFS（Progression-Free Survival） assessed by IRRC according to mRECIST.
Measured: up to 2 years
Phase III: DoR（Duration of Response） assessed by IRRC according to mRECIST.
Measured: up to 2 years
Phase III: DCR（Disease Control Rate） assessed by IRRC according to mRECIST.
Measured: up to 2 years
Phase III: TTR（Time to Response） assessed by IRRC according to mRECIST.
Measured: up to 2 years
Phase III: incidence rate of AEs（Adverse Event）
Measured: up to 2 years
Phase III: incidence rate of TEAEs（Treatment Emergent Adverse Event）
Measured: up to 2 years
Phase III: incidence rate of SAEs（Serious Adverse Event）
Measured: up to 2 years
Phase III: Cmax
One of the Pharmacokinetics parameters
Measured: up to 2 years
Phase III: CL(Clearance)
One of the Pharmacokinetics parameters
Measured: up to 2 years
Phase III: t1/2 (Half-Life)
One of the Pharmacokinetics parameters
Measured: up to 2 years
Phase III: Volume
One of the Pharmacokinetics parameters
Measured: up to 2 years
Phase III: AUC (Area Under the Curve)
One of the Pharmacokinetics parameters
Measured: up to 2 years
Phase III: Incidence and characteristics of ADA&Nab.
Measured: up to 2 years
Phase II: Volume（PK）
One of the Pharmacokinetics parameters
Measured: up to 2 years
Phase II: t1/2 (Half-Life)
One of the Pharmacokinetics parameters
Measured: up to 2 years
phase III: score of (European Organization for Research and Treatment of Cancer, EORTC）EORTC QLQ-C30
Measured: up to 2 years
phase III: score of (Eropean Organization for Research and Treatment of Cancer, EORTC）EORTC QLQ-HCC18
Measured: up to 2 years
Phase II: CL (Clearance)
One of the Pharmacokinetics parameters
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start27 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490262
- Sponsor's protocol ID
- CIBI310C302
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy as First-line Treatment in Previously Untreated Patients With Unresectable or Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07490262
- Acronym / sponsor ID
- CIBI310C302
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Mar 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.
This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Biological: Bevacizumab, Biological: SintilimabSintilimab+ Bevacizumab |
| Treatment Group2 | Experimental | Biological: Bevacizumab, Biological: IBI310, Biological: SintilimabSintilimab+ IBI310+Bevacizumab |
| Treatment Group3 | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Biological: IBI310, Biological: SintilimabSintilimab+ IBI310+Oxaliplatin+Capecitabine |
| Treatment Group1 | Experimental | Biological: Bevacizumab, Drug: Capecitabine, Drug: Oxaliplatin, Biological: IBI310, Biological: SintilimabSintilimab+ IBI310+Bevacizumab+Oxaliplatin+Capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuitable for curative-intent surgery and/or locoregional therapy.
- No prior systemic antineoplastic therapy for HCC before first dose.
Key exclusion criteria (34 listed)
- Histologically or cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, or other mixed hepatic malignancies containing these components.
- History of hepatic encephalopathy or prior liver transplantation.
- Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring therapeutic drainage; participants with only minimal (radiologically detected), asymptomatic effusions may be enrolled.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection:
- Known central nervous system (CNS) metastases or symptomatic spinal cord compression.
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 |
|---|---|---|
| Bevacizumab15 mg/kg intravenous infusion, administered on Day 1 of each 3-week treatment cycle | Biological | Control Group, Treatment Group1, Treatment Group2 |
| Capecitabine1000 mg/m² orally, administered on Days 1-14 of each 3-week treatment cycle, maximum 4 cycles. | Drug | Treatment Group1, Treatment Group3 |
| Oxaliplatin85 mg/m² intravenous infusion, administered on Day 1 of each 3-week treatment cycle, maximum 4 cycles. | Drug | Treatment Group1, Treatment Group3 |
| IBI3101 mg/kg intravenous infusion, administered on Day 1 of each 6-week treatment cycle | Biological | Treatment Group1, Treatment Group2, Treatment Group3 |
| Sintilimab200 mg intravenous infusion, administered on Day 1 of each 3-week treatment cycle | Biological | Control Group, Treatment Group1, Treatment Group2, Treatment Group3 |
Primary outcome
Phase II: ORR （Objective Response Rate） assessed by investigator per RECIST 1.1.
Time frame: up to 2 years
Phase II: PFS（Progression-Free Survival） assessed by investigator per RECIST 1.1.
Time frame: up to 2 years
Phase II: AEs（Adverse Event）
Time frame: up to 2 years
Phase II: TRAES（Treatment Emergent Adverse Event）
Time frame: up to 2 years
Phase II: SAEs（Serious Adverse Event）
Time frame: up to 2 years
Phase III: OS（Overall Survival）
Time frame: up to 2 years
Phase III: PFS（Progression-Free Survival）assessed by the Independent Radiologic Review Committee (IRRC) per RECIST 1.1.
Time frame: up to 2 years
36 secondary outcomes
Phase II: OS
Time frame: up to 2 years
Phase II: Incidence and characteristics of ADA&Nab.
Time frame: up to 2 years
Phase II: DoR (Duration of Response )
Time frame: up to 2 years
Phase II: DCR (Disease Control Rate )
Time frame: up to 2 years
Phase II: TTR (Time to Response )
Time frame: up to 2 years
Phase II:Cmax (maximum plasma concentration)
Time frame: up to 2 years
Phase II:Tmax (time to reach maximum concentration)
Time frame: up to 2 years
Phase II: AUC (time curve)
Time frame: up to 2 years
PhaseIII: ORR （Objective Response Rate）assessed by IRRC according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: DoR （Duration of Response）assessed by IRRC according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: DCR （Time to Response）assessed by IRRC according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: TTR（Time to Response） assessed by IRRC according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: ORR （Objective Response Rate）assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: PFS （Progression-Free Survival）assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: DoR （Duration of Response）assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: DCR（Time to Response） assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: TTR (Time to Response) assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
Phase III: ORR （Objective Response Rate）assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: PFS（Progression-Free Survival） assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: DoR（Duration of Response） assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: DCR（Disease Control Rate） assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: TTR（Time to Response） assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: incidence rate of AEs（Adverse Event）
Time frame: up to 2 years
Phase III: incidence rate of TEAEs（Treatment Emergent Adverse Event）
Time frame: up to 2 years
Phase III: incidence rate of SAEs（Serious Adverse Event）
Time frame: up to 2 years
Phase III: Cmax
Time frame: up to 2 years
Phase III: CL(Clearance)
Time frame: up to 2 years
Phase III: t1/2 (Half-Life)
Time frame: up to 2 years
Phase III: Volume
Time frame: up to 2 years
Phase III: AUC (Area Under the Curve)
Time frame: up to 2 years
Phase III: Incidence and characteristics of ADA&Nab.
Time frame: up to 2 years
Phase II: Volume（PK）
Time frame: up to 2 years
Phase II: t1/2 (Half-Life)
Time frame: up to 2 years
phase III: score of (European Organization for Research and Treatment of Cancer, EORTC）EORTC QLQ-C30
Time frame: up to 2 years
phase III: score of (Eropean Organization for Research and Treatment of Cancer, EORTC）EORTC QLQ-HCC18
Time frame: up to 2 years
Phase II: CL (Clearance)
Time frame: up to 2 years
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 16 Apr 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bevacizumab, Capecitabine and Oxaliplatin in people with Hepatocellular Carcinoma (HCC), run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. at 2 sites 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 11 inclusion and 34 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Haiyun Zuo (021-31852088, Haiyun.zuo@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II: ORR （Objective Response Rate） assessed by investigator per RECIST 1.1. (time frame: up to 2 years). The study lists 7 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 16 Apr 2026.