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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This study is being done to analyze the safety, tolerability, and efficacy of treatment using combination of SAM and anti-PD-1/PDL1 antibodies for patients with advanced hepatocellular carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
View:

• ≥18 years old, male or female

• 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

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

• Patient has given written informed consent.

• The function of important organs meets the requirements

• Expected survival ≥12 weeks

• 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.

Locations
Other Locations
China
Zhongshan Hospital Fudan university
RECRUITING
Shanghai
Contact Information
Primary
Mincheng Yu
yumincheng94@gmail.com
2164041990
Time Frame
Start Date: 2023-01-26
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Anti-PD-1/PD-L1 antibodies and S-adenosyl-methionine combination
Drug: Anti-PD-1/PD-L1 Intravenous injection for at least 6 months~Drug: S-adenosyl-methionine Taken orally for at least 6 months
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov