Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jul 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with hepatocellular carcinoma, which is a type of liver cancer. The study aims to see how safe and effective a combination of cryoablation (a procedure that freezes cancer cells), a PD-1 antibody (a type of drug that helps the immune system attack cancer), and bevacizumab (another medication that prevents tumors from growing) is for patients whose cancer has not responded well to previous treatments.

To participate, individuals need to be between 18 and 80 years old and have been diagnosed with hepatocellular carcinoma that has progressed after PD-1/L1 treatment. They should also have a good level of liver function and be well enough to undergo the procedure. Not everyone will qualify, as certain health conditions and other factors could exclude some patients. Those who participate will be closely monitored throughout the trial to ensure their safety and to evaluate how well the treatment works. This study is not yet recruiting participants, but it represents an important step in exploring new options for managing this challenging cancer.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 80 years old, and expected survival is longer than 3 months
• • 2. Clinically or pathologically diagnosed as primary hepatocellular carcinoma
• • 3. Disease progression assessed according to mRECIST criteria after PD-1/L1 antibody treatment
• • 4. Child-Pugh score of liver function A/B (\< 7)
• • 5. At least one lesion is suitable for mRECIST assessment
• • 6. Strength score (ECOG): 0-1
• • 7. The patient and/or family members agree to join the clinical trial and sign the informed consent form
• Exclusion Criteria:
• • 1. Patients whose tumor lesions are not suitable for ablation as assessed by the surgeon
• • 2. Tumor burden greater than ≥70%, or tumor is not suitable for mRECIST standard evaluation
• • 3. Patients with chronic viral hepatitis (hepatitis B, hepatitis C) have a viral load greater than 10\^4 before receiving treatment or do not continue to take antiviral drugs regularly
• • 4. Pregnant patients
• • 5. Combined with other malignant tumors, or have a history of other malignant tumors within 3 years
• • 6. Active autoimmune disease, confirmed immunodeficiency, history of systemic steroid medication
• • 7. Severe renal dysfunction: creatinine (Cr) \> 2 mg/dL or creatinine clearance (CCr) \<30 mL/min, severe heart, lung, brain and other important organ diseases
• • 8. History of gastrointestinal bleeding within 3 months
• • 9. Unable to cooperate with ablation surgery
• • 10. Severe gastroesophageal varices