BridgeMD
Tests treatment safety and results for Hepatocellular Carcinoma (HCC)
Official title A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.
ClinicalTrials.gov ID: NCT07490262
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- Histologically or cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, or other...
- History of hepatic encephalopathy or prior liver transplantation.
- Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring therapeutic drainage; participants with only minimal...
- 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...
See the full eligibility criteria
Who can 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).
- 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...
- Signed written informed consent form, and ability to comply with scheduled visits and all protocol-specified procedures.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.