Combining anti-PD-1/PD-L1 antibodies with S-adenosyl-methionine for advanced liver cancer

Phase I/II Study of Anti-PD-1/PD-L1 Antibodies Combined With S-adenosyl-methionine in Patients With Advanced-Stage Hepatocellular Carcinoma

This study is testing if combining a new cancer treatment with a supplement can help adults with advanced liver cancer feel better and live longer.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Drugs / interventions: prednisone, pembrolizumab, nivolumab, sintilimab, toripalimab, camrelizumab, tislelizumab, atezolizumab
• Locations: 1 site (Shanghai)
• Trial ID: NCT05701553 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and efficacy of combining S-adenosyl-methionine (SAM) with anti-PD-1/PD-L1 antibodies in adult patients with advanced hepatocellular carcinoma (HCC). Participants will receive intravenous treatments of these antibodies alongside SAM, which is known for its role in regulating cancer cell proliferation. The study aims to determine how well this combination works in patients whose cancer cannot be surgically removed. Treatment will continue until disease progression, intolerable toxicity, or withdrawal of consent.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced, unresectable hepatocellular carcinoma and a good performance status.

Not a fit: Patients with active autoimmune diseases or those who do not meet the organ function requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced hepatocellular carcinoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and supportive treatments, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. ≥18 years old, male or female
2. Advanced hepatocellular carcinoma (cannot be removed or metastasized) diagnosed clinically or pathologically, at least one measurable lesion without local treatment, Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
4. Patient has given written informed consent.
5. The function of important organs meets the requirements
6. Expected survival ≥12 weeks
7. Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period.

Exclusion Criteria:

1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included);
2. The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment;
3. Have clinical symptoms or disease that are not well controlled;
4. Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization;
5. Arterial/venous thrombosis in the first 6 months of randomization
6. According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.#with family or social factors, it will affect the safety of patients.
7. Liver tumor burden greater than 50% of the total liver volume, or patients who have previously undergone liver transplantation;Known for a history of central nervous system metastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonal antibodies;

Where this trial is running

Shanghai

• Zhongshan Hospital Fudan university — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jia Fan — Fudan University
• Study coordinator: Mincheng Yu

Conditions Hepatocellular Carcinoma; Anti-PD-1 antibody; Anti-PD-L1 antibody; SAM