Combining ablation with lenvatinib and anti-PD-1 antibodies for liver cancer treatment

Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies in Patients With Early Recurrence After Radical Resection/Ablation of HCC: a Prospective, Randomized, Controlled Clinical Study

This study is testing if combining a cancer drug called lenvatinib with immune therapy and a procedure to destroy tumors can help people with recurring liver cancer feel better and live longer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Drugs / interventions: radiation, prednisone, Cindilimab, Lenvatinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05803928 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining lenvatinib, a multi-target receptor tyrosine kinase inhibitor, with anti-PD-1 antibodies and ablation therapy in patients with recurrent hepatocellular carcinoma. The study aims to evaluate the safety and efficacy of this combination treatment in patients who have experienced recurrence after radical surgery or ablation. Participants will be monitored for tumor progression and overall survival, with a focus on improving treatment outcomes compared to existing therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with recurrent hepatocellular carcinoma that meets specific criteria after prior surgical intervention.

Not a fit: Patients with extrahepatic metastasis or those with severe liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients with recurrent liver cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and immunotherapy in treating liver cancer, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years old, ≤75 years old, gender unlimited;
2. primary hepatocellular carcinoma proved pathologically and clinically;
3. 2 months after radical resection or ablation, imaging examination (MRI, CT plain enhanced) showed no tumor lesions, HCC recurred within 3 years after surgery, no extrahepatic metastasis;
4. ECOG score 0-1;
5. Recurrent liver cancer meets the Milan criteria: single tumor diameter ≤5cm or multiple tumors less than 3 with a maximum diameter ≤3cm, no major vascular invasion, no lymph node metastasis or extrahepatic metastasis;
6. Child-Pugh liver function grades: A, B;
7. Expected survival \> 6 months;
8. Adequate organ function: ① no need for growth factors and blood components within 2 weeks prior to enrollment; (2) Cardiac function: no heart disease, coronary heart disease, cardiac function level 1-2; ③ In the first 7 days of enrollment, liver and kidney function was adequate and laboratory indicators were suitable (untreated) : HGB≧9.0g/dl, neutrophils ≧1,500/mm3, PLT≧50x109/L, serum ALB≧28g/L, TBIL\<2mg /dL, ALT, AST\< 5 times of the upper limit of normal value, Bun, Cr\< 1.5 times of the upper limit of normal value, INR\<1.7 or extended PT\<3s;
9. Patients with normal blood pressure or hypertension should use antihypertensive drugs to control blood pressure within the normal range;
10. Diabetic patients should control fasting blood glucose ≤8mmol/L by hypoglycemic drugs;
11. No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation, etc.) that conflict with the Plan;
12. No history of other malignant tumors;
13. Women of childbearing age must have a negative blood pregnancy test within seven days, and subjects of childbearing age must use appropriate contraception during the test and for six months after the test;
14. The patient agrees to participate in the clinical study and sign the Informed Consent.

Exclusion Criteria:

* (1) previous radiotherapy, hormone therapy or molecular targeted therapy; (2) Patients with distant metastasis confirmed by imaging; (3) The subject has had or co-has other malignancies (other than cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); (4) The subject is known to be allergic to macromolecular protein preparations, or to any component of anti-PD-1 antibodies; (5) Subject has any history of active autoimmune disease or autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with childhood leukoplectic disease or complete remission of asthma can be incorporated into adults without any intervention; Subjects requiring medical intervention with bronchodilators are not included; (6) Subjects were taking immunosuppressants, or systemic or absorbable topical hormone therapy for immunosuppressive purposes (doses \>10mg/ day of prednisone or other therapeutic hormones) and were still taking them within 2 weeks prior to enrollment; (7) Clinical symptoms of heart disease or disease not well controlled, such as: heart failure of grade 2 or above A.N. B. Unstable angina pectoris; C. Myocardial infarction within 1 year; D. Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (8) Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\>2g/L), bleeding tendency or receiving thrombolytic or anticoagulant therapy; (9) The patient has current (within 3 months) gastrointestinal conditions such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from unexcised tumors, or other conditions identified by the investigator as likely to cause gastrointestinal bleeding and perforation; (10) Previous or current severe bleeding (bleeding \>30 ml within 3 months), hemoptysis (fresh blood \>5 ml within 4 weeks), or thromboembolic events (including stroke events and/or transient brain dysfunction) within 12 months; (11) Previous and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, severe impairment of lung function, etc.; (12) of congenital or acquired immune deficiency, such as HIV infection, active hepatitis (transaminase does not meet the criteria for the hepatitis b reference: HBV DNA of 10 or higher ⁴ / ml; Hepatitis C reference: HCV RNA≥103/ml); Chronic hepatitis B virus carriers with HBV DNA\<2000 IU/ml (\<104 copies /ml) must also receive antiviral therapy during the trial to be enrolled; (13) Subjects are participating in other clinical studies or less than one month has passed since the end of the previous clinical study; Subjects may receive other systemic antitumor therapies during the study; (14) The subject is known to have a history of psychotropic, alcohol, or drug abuse; (15) Imaging examination confirmed tumor recurrence or metastasis 2 months after surgery; (16) The researcher believes that it should be excluded from this study. For example, in the researchers' judgment, the subjects had other factors that might have led to the study's termination, such as other serious medical conditions (including mental illness) requiring combination treatment. Serious laboratory abnormalities, accompanied by family or social factors, may affect the safety of the subject or the collection of data and samples.

Where this trial is running

Guangzhou, Guangdong

• Third Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Hua Li

Conditions Hepatocellular Carcinoma