Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation

Hepatocellular Carcinoma Clinical Trial

Official title:

Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248554
• Other study ID #: HOPE-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: WanGuang D Zhang
• Phone: +8613886195965
• Email: wgzhang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. However, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. Therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy.

Description:

For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. However, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. Therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy. There is no consensus on postoperative adjuvant therapy, especially for the management of early-stage HCC. Most scholars believe that HCC in this period does not have high-risk factors for tumor recurrence, thus neglecting the role of adjuvant therapy. Early studies have found that microwave ablation can alter the tumor microenvironment, which is conducive to the action of immune checkpoint inhibitors such as PD-1 inhibitors and even has a synergistic anti-tumor effect. We therefore designed this prospective cohort study to explore the efficacy and safety of adjuvant PD-1 inhibitors after microwave surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 18-75 years
• Pathological type is HCC, BCLC stage 0-A
• No extrahepatic HCC
• No radiographic recurrence at 2-4 weeks after ablation
• Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
• Child-Pugh grade A or B and adequate hematologic and organ function

Exclusion Criteria:

• Any history of other malignant tumors or recurrent HCC
• Any preoperative treatment for HCC including local and systemic therapy
• Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
• Any persistent serious ablation-related complications
• Esophageal and/or gastric variceal bleeding within 6 months
• Inability or refusal to comply with the treatment and monitoring
• Participation in other clinical trials

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• PD-1 Inhibitors
Patients in the intervention group received post-operative adjuvant PD-1 inhibitor therapy, 240 mg intravenously every three weeks for nine cycles

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China	WuHan

Sponsors (1)

Lead Sponsor	Collaborator
Chen Xiaoping

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Disease-free survival was defined as the period from inclusion in the study until tumor recurrence, death from any cause.	From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months
Secondary	Overall survival	Overall survival was defined as the period from study inclusion until death from any cause.	From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months
Secondary	Adverse effects	Adverse reactions are defined as any reaction during treatment that is inconsistent with the purpose of the treatment.	6 months