HCC - Hepatocellular CarcinomaPhase 1/2NCT07761286
Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma
A Phase 1/2 study testing SYS6090 Injection + Bevacizumab Injection, SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection and Bevacizumab Injection + Sintilimab Injection in people with HCC - Hepatocellular Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of combination therapy with SYS6090 Injection in participants with hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- SYS6090 Injection + Bevacizumab Injection, SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection and Bevacizumab Injection + Sintilimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Sep 2031
- Phase
- Phase 1/2
- 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
- The participant voluntarily signs the informed consent form.
- Aged ≥18 years at the time of informed consent acquisition.
- Confirmed diagnosis of hepatocellular carcinoma (HCC) via histopathology, cytopathology, or clinical diagnosis in accordance with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2026 Edition).
- Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B unsuitable for curative surgery and/or locoregional therapy.
- Child-Pugh score <7 and no history of hepatic encephalopathy.
- No prior systemic anti-tumor therapy for HCC. Prior systemic therapy administered in the neoadjuvant or adjuvant setting is permitted, provided that the time from the last dose of prior therapy to tumor recurrence is ≥6 months.
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- At least one measurable lesion per RECIST Version 1.1. Lesions previously treated with interventional therapy, radiotherapy or ablation may be counted as measurable lesions if clear disease progression is documented per RECIST v1.1 and the lesion meets measurable lesion criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Expected survival ≥3 months.
- Adequate organ function as defined below:
- Hematology: PLT ≥100×10⁹/L; Hb ≥90 g/L; ANC ≥1.5×10⁹/L (no blood transfusion, platelet transfusion or hematopoietic stimulating factor administered within 14 days prior to hematology testing at screening);
- Liver function: AST and ALT ≤5×ULN; TBIL ≤1.5×ULN;
- Renal function: Ccr >50 mL/min (calculated by the Cockcroft-Gault formula); urine protein <2+; participants with urine protein ≥2+ must have a 24-hour urine protein quantification <1 g;
- Coagulation function: APTT ≤1.5×ULN; INR ≤1.5×ULN. Participants receiving full-dose oral anticoagulants must maintain a stable dose for a minimum of 14 days;
- Albumin: ≥30 g/L (equivalent to ≥3.0 g/dL).
- Fertile eligible participants (male and female) must agree to use reliable contraceptive methods together with their partners throughout the study period and for at least 7 months after the last study drug administration (hormonal contraceptives, barrier methods, or abstinence). Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.
- Willing and able to comply with all study requirements.
Who cannot join
- Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma.
- Received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any investigational trial intervention within 4 weeks prior to the first study drug administration or within 5 half-lives of the most recent anti-tumor agent (whichever is shorter); or received Chinese patent medicines with anti-tumor indications, palliative radiotherapy, or locoregional therapy within 14 days prior to the first study drug administration.
- Underwent major visceral surgery (excluding core needle biopsy) or sustained severe trauma within 4 weeks prior to the first study drug administration, or planned elective surgery during the study period.
- Received systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first study drug administration, except for the following scenarios: physiologic replacement doses of hydrocortisone or equivalent hormones (i.e., prednisone ≤10 mg/day or equivalent); topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-course corticosteroids for prophylaxis (e.g., prophylaxis against contrast medium allergy).
- Received live vaccines within 4 weeks prior to the first study drug administration. Note: Seasonal influenza vaccines are inactivated vaccines in general and are permitted. Intranasal influenza vaccines are live vaccines and are prohibited.
- Received strong CYP3A4 inhibitors/inducers, or OATP1B1/OATP1B3 inhibitors within 14 days prior to the first study drug administration, or require continuous use of such agents throughout the study period.
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- Adverse reactions from prior anti-tumor therapy have not recovered to Grade ≤1 per NCI CTCAE v6.0 (excluding toxicities judged by the Investigator to carry no safety risks, such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stabilized with hormone replacement therapy, etc.).
- History of or current central nervous system metastases and/or carcinomatous meningitis; current untreated spinal cord compression (excluding participants with previously diagnosed treated spinal cord compression with documented clinically stable symptoms for more than 2 weeks prior to screening).
- Active infection requiring intravenous anti-infective therapy within 14 days prior to the first study drug administration.
- Symptomatic moderate or severe ascites within 14 days prior to the first dose or at screening (excluding minor ascites only visible on imaging without clinical symptoms); or uncontrolled moderate or larger pleural effusion or pericardial effusion.
- Tumor thrombus involving both the main portal vein and left/right portal branches simultaneously; tumor thrombus involving both the main portal vein and superior mesenteric vein simultaneously; or tumor thrombus involving the inferior vena cava.
- Esophageal or gastric variceal bleeding secondary to portal hypertension, or any life-threatening bleeding event within 6 months prior to the first study drug administration (including events requiring blood transfusion, surgery, locoregional intervention, or sustained medical treatment); known severe esophageal/gastric varices on endoscopy without definitive treatment within 3 months prior to the first study drug administration; other gastrointestinal bleeding events, active gastric or duodenal ulcer within 28 days prior to screening.
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or intestinal obstruction within 6 months prior to the first study drug administration.
- Presence of severe unhealed wounds or untreated fractures at screening.
- Current interstitial pneumonia/interstitial lung disease; prior history of interstitial pneumonia/interstitial lung disease requiring corticosteroid treatment; or other pulmonary conditions that may interfere with the identification and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia, active pulmonary tuberculosis, etc.
- Active hepatitis B at screening [positive HBsAg or HBcAb with active viral replication (HBV DNA ≥2000 IU/mL)]; hepatitis C (positive Anti-HCV antibody with positive HCV RNA PCR); active syphilis infection (positive TP-Ab plus positive TRUST/RPR); HIV infection; or concurrent co-infection with both hepatitis B and hepatitis C.
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- NYHA Class II or higher congestive heart failure, unstable angina, or myocardial infarction occurring within 6 months prior to the first study drug administration;
- Severe cardiac rhythm or conduction abnormalities requiring clinical intervention, such as ventricular arrhythmias, second- or third-degree atrioventricular block (participants may be eligible if the Investigator assesses no significant risks);
- Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);
- Clinically significant history of QT interval prolongation, or QTcF (calculated via Fridericia's formula) > 480 ms at screening, or left ventricular ejection fraction < 50%;
- Arterial or venous thromboembolic events within 6 months prior to the first study drug administration, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc. Participants with stable thrombosis may be enrolled if the Investigator determines no cardiovascular risks.
- Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg).
- Active or recurrent autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for the following conditions:
- Autoimmune thyroid disease with clinically stable status;
- Type 1 diabetes managed with hormone replacement therapy;
- Autoimmune skin disorders well controlled with topical therapy (e.g., low-potency topical corticosteroids) without acute exacerbations requiring additional treatment within 12 months before screening (e.g., eczema, psoriasis, lichen simplex chronicus, or vitiligo involving <10% of total body surface area).
- Prior immunotherapy complicated with Grade ≥3 immune-related adverse events (irAEs) or Grade ≥2 immune-related myocarditis (excluding stabilized immune-related endocrine abnormalities).
- Known hypersensitivity to any component of the study treatment; history of hypersensitivity to premedications; or poorly controlled asthma (presentation of three or more asthma symptoms with partially controlled or uncontrolled status).
- Female participants who are pregnant or breastfeeding.
- History of other malignant tumors within 2 years prior to the first dose, or concurrent active malignant tumors (participants with cured localized tumors may be enrolled, including basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, breast carcinoma in situ, etc.).
- Known alcohol or drug dependence; or other severe systemic medical conditions deemed by the Investigator to render the participant unsuitable for participation in this clinical study for any other reason.
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
Harbin medical university Cancer Hospital
Harbin, Heilongjiang, 150000
tongsen NA Zheng, +86-0451-86298278, zhengtongsen@126.com
About this study
Official title: Phase Ib/II Study to Evaluate the Safety, Tolerability and Efficacy of Combination Therapy With SYS6090 Injection in Participants With Hepatocellular Carcinoma
This is an open-label, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of combination therapy with SYS6090 Injection in participants with hepatocellular carcinoma (HCC).
Read the detailed description
The study design consists of two phases. Phase Ib is a dose-escalation and dose-expansion study, with the primary objectives to evaluate the safety, tolerability and preliminary efficacy of SYS6090 combination therapy and identify the recommended dose for the combination regimen. Phase II is a randomized controlled trial (RCT) that with the objective to further assesses the efficacy and safety of SYS6090 combination therapy versus a positive control group.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- SYS6090 Injection + Bevacizumab Injection, SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection, Bevacizumab Injection + Sintilimab Injection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6090 Injection + Bevacizumab InjectionDrug
SYS6090 in Combination with Bevacizumab 15mg/kg
SYS6090 Injection +SYS6043 Injection +Bevacizumab InjectionDrug
SYS6090 in Combination with SYS6043 and Bevacizumab 15mg/kg
Bevacizumab Injection + Sintilimab InjectionDrug
Bevacizumab 15mg/kg in Combination with Sintilimab 200mg, intravenous infusion, every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SYS6090+ BEV | Experimental | Not described Receives: Drug: SYS6090 Injection + Bevacizumab Injection |
| SYS6090+SYS6043+ BEV | Experimental | Not described Receives: Drug: SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection |
| BEV + SIN | Experimental | Not described Receives: Drug: Bevacizumab Injection + Sintilimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluated incidence and severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per NCI-CTCAE version 6.0, including abnormal laboratory tests, ECG parameters and vital signs from screening through end of safety follow-up.
Measured: Up to 2 years.
Overall response rate (ORR)
ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with at least one visit confirmed complete response (CR) or partial response (PR).
Measured: Up to 2 years.
DLT；RP2D and MTD
The Phase Ib study will explore the DLTs and MTD of SYS6090 combination therapy, and the RP2D will be determined based on the results from the Phase Ib study.
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 posted12 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be assigned to one of three treatment arms: SYS6090 plus bevacizumab, SYS6090 plus bevacizumab and SYS6043, or bevacizumab plus sintilimab.
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761286
- Sponsor's protocol ID
- SYS6090-007
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 12 Aug 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study to Evaluate the Safety, Tolerability and Efficacy of Combination Therapy With SYS6090 Injection in Participants With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07761286
- Acronym / sponsor ID
- SYS6090-007
- Conditions
- HCC - Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 12 Aug 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 is an open-label, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of combination therapy with SYS6090 Injection in participants with hepatocellular carcinoma (HCC).
Detailed description
The study design consists of two phases. Phase Ib is a dose-escalation and dose-expansion study, with the primary objectives to evaluate the safety, tolerability and preliminary efficacy of SYS6090 combination therapy and identify the recommended dose for the combination regimen. Phase II is a randomized controlled trial (RCT) that with the objective to further assesses the efficacy and safety of SYS6090 combination therapy versus a positive control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be assigned to one of three treatment arms: SYS6090 plus bevacizumab, SYS6090 plus bevacizumab and SYS6043, or bevacizumab plus sintilimab.
| Arm | Type | Receives |
|---|---|---|
| SYS6090+ BEV | Experimental | Drug: SYS6090 Injection + Bevacizumab Injection |
| SYS6090+SYS6043+ BEV | Experimental | Drug: SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection |
| BEV + SIN | Experimental | Drug: Bevacizumab Injection + Sintilimab Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The participant voluntarily signs the informed consent form.
- Aged ≥18 years at the time of informed consent acquisition.
- Confirmed diagnosis of hepatocellular carcinoma (HCC) via histopathology, cytopathology, or clinical diagnosis in accordance with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2026 Edition).
- Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B unsuitable for curative surgery and/or locoregional therapy.
- Child-Pugh score <7 and no history of hepatic encephalopathy.
Key exclusion criteria (32 listed)
- Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma.
- Received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any investigational trial intervention within 4 weeks prior to the first study drug administration or within 5 half-lives of the most recent anti-tumor agent (whichever is shorter); or received Chinese patent medicines with anti-tumor indications, palliative radiotherapy, or locoregional therapy within 14 days prior to the first study drug administration.
- Underwent major visceral surgery (excluding core needle biopsy) or sustained severe trauma within 4 weeks prior to the first study drug administration, or planned elective surgery during the study period.
- Received systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first study drug administration, except for the following scenarios: physiologic replacement doses of hydrocortisone or equivalent hormones (i.e., prednisone ≤10 mg/day or equivalent); topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-course corticosteroids for prophylaxis (e.g., prophylaxis against contrast medium allergy).
- Received live vaccines within 4 weeks prior to the first study drug administration. Note: Seasonal influenza vaccines are inactivated vaccines in general and are permitted. Intranasal influenza vaccines are live vaccines and are prohibited.
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 |
|---|---|---|
| SYS6090 Injection + Bevacizumab InjectionSYS6090 in Combination with Bevacizumab 15mg/kg | Drug | SYS6090+ BEV |
| SYS6090 Injection +SYS6043 Injection +Bevacizumab InjectionSYS6090 in Combination with SYS6043 and Bevacizumab 15mg/kg | Drug | SYS6090+SYS6043+ BEV |
| Bevacizumab Injection + Sintilimab InjectionBevacizumab 15mg/kg in Combination with Sintilimab 200mg, intravenous infusion, every 3 weeks. | Drug | BEV + SIN |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2 years.
Evaluated incidence and severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per NCI-CTCAE version 6.0, including abnormal laboratory tests, ECG parameters and vital signs from screening through end of safety follow-up.
Overall response rate (ORR)
Time frame: Up to 2 years.
ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with at least one visit confirmed complete response (CR) or partial response (PR).
DLT；RP2D and MTD
Time frame: Up to 2 years.
The Phase Ib study will explore the DLTs and MTD of SYS6090 combination therapy, and the RP2D will be determined based on the results from the Phase Ib study.
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 12 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SYS6090 Injection + Bevacizumab Injection, SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection and Bevacizumab Injection + Sintilimab Injection in people with HCC - Hepatocellular Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd. 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 17 inclusion and 32 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 12 Aug 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Clinical Trials Information Group officer (0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 2 years.). The study lists 3 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 12 Aug 2026.