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Tests treatment safety and results for HCC
Official title Efficacy and Safety of Sintilimab Combined With Lenvatinib and HAIC for Neoadjuvant Therapy of Borderline Resectable HCC
ClinicalTrials.gov ID: NCT06904014
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for 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 single-center, randomized controlled exploratory Phase II clinical trial, aiming to assess the efficacy and safety of sintilimab combined with lenvatinib and HAIC for two cycles followed by surgery compared with direct surgery in patients with borderline resectable hepatocellular carcinoma. After signing the informed consent and meeting the inclusion and exclusion criteria, the eligible subjects were randomly divided into the experimental group and the control group: Subjects in the experimental group received 200 mg of sintilimab by intravenous infusion on the first day of every 3 weeks.
- Phase 2: a mid-size study of how well it works
- 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 70
You may be able to join if
- Sign a written informed consent before the implementation of any trial-related procedures.
- Male or female, aged ≥18 years and ≤70 years.
- ECOG PS score of 0-2.
- Diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer in China (2019 Edition).
- CNLC stage IIIa, with vascular invasion but no extrahepatic metastasis.
You likely can't join if
- Previously histologically/cytologically confirmed liver cancer with components such as fibrolamellar hepatocellular carcinoma, sarcomatoid...
- History of hepatic encephalopathy or liver transplantation.
- Clinical symptoms requiring drainage of pleural effusion, ascites, or pericardial effusion.
- Acute or chronic active hepatitis B or C infection, with HBV DNA \> 2000 IU/ml or 104 copies/ml; HCV RNA \> 103 copies/ml; positive for both...
- Central nervous system metastasis.
- Esophageal or gastric variceal bleeding events due to portal hypertension within the past 6 months. Known severe (G3) varices on endoscopy within 3...
See the full eligibility criteria
Who can join
- Sign a written informed consent before the implementation of any trial-related procedures.
- Male or female, aged ≥18 years and ≤70 years.
- ECOG PS score of 0-2.
- Diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer in China (2019 Edition).
- CNLC stage IIIa, with vascular invasion but no extrahepatic metastasis.
- Child-Pugh score of A/B.
- Portal vein tumor thrombus is classified as type 1-2 according to the Japanese VP classification or type I-II according to the Program classification.
- No previous systemic anti-tumor treatment for hepatocellular carcinoma and eligible for R0 resection.
- Expected survival time \> 3 months.
- At least one measurable lesion according to RECIST 1.1 or mRECIST criteria.
- Adequate organ and bone marrow function, as follows: 1) Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109/L; platelet count (PLT) ≥ 75×109/L; hemoglobin content (HGB) ≥ 9.0 g/dL. 2) Liver function: serum total...
What rules you out
- Previously histologically/cytologically confirmed liver cancer with components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
- History of hepatic encephalopathy or liver transplantation.
- Clinical symptoms requiring drainage of pleural effusion, ascites, or pericardial effusion.
- Acute or chronic active hepatitis B or C infection, with HBV DNA \> 2000 IU/ml or 104 copies/ml; HCV RNA \> 103 copies/ml; positive for both hepatitis B surface antigen (HbsAg) and anti-HCV antibody.
- Central nervous system metastasis.
- Esophageal or gastric variceal bleeding events due to portal hypertension within the past 6 months. Known severe (G3) varices on endoscopy within 3 months before the first dose. Evidence of portal hypertension...
- Any life-threatening bleeding events within the past 3 months, including those requiring blood transfusion, surgery or local treatment, or continuous drug treatment.
- Venous or arterial thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any...
- Use of aspirin (\> 325 mg/day) or other known platelet function inhibitors such as dipyridamole or clopidogrel for 10 consecutive days within 2 weeks before the first dose.
- Uncontrolled hypertension, with systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg after optimal medical treatment, or history of hypertensive crisis or hypertensive encephalopathy.
- Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected QTc \> 500 ms (calculated using the Fridericia method) at...
- Severe bleeding tendency or coagulation disorders, or currently undergoing thrombolytic therapy.
- History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal...
- Received radiotherapy within 3 weeks before the first dose. For patients who received radiotherapy more than 3 weeks before the first dose, all of the following conditions must be met to be eligible for inclusion: no...
- History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung function impairment.
- Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), or known syphilis infection.
- Active or poorly controlled severe infection. Severe infection within 4 weeks before the first dose, including but not limited to hospitalization due to infection, bacteremia, or complications of severe pneumonia.
- Active or poorly controlled autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose. Use of replacement therapy (e.g...
- Use of immunosuppressive drugs within 4 weeks before the first dose, excluding nasal sprays, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (i.e., no more than 10mg/day of...
- Receipt of live attenuated vaccines within 4 weeks before the first dose or planned during the study period.
- Receipt of local treatment for liver cancer within 4 weeks before the first dose.
- Receipt of traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural or ascitic fluid) within 2...
- Uncontrolled or uncorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions of cancer that may lead to higher medical risks and/or uncertainty in survival...
- Diagnosis of other malignancies within 5 years before the first dose, excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ carcinoma that have been completely resected. If other malignancies...
- Previous receipt of any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy.
- Known allergy to any component of sintilimab, lenvatinib, or chemotherapy drugs; or previous severe allergic reactions to other monoclonal antibodies or tyrosine kinase inhibitors.
- Receipt of treatment in other clinical trials within 4 weeks before the first dose.
- Pregnant or lactating female patients.
- Other acute or chronic diseases, mental disorders, or abnormal laboratory test values that may lead to the following results: increased risks associated with study participation or administration of the study drug, or...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, 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.