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

NCT ID: NCT06248554

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 inhibitor adjuvant therapy group

Received adjuvant PD-1 inhibitor 2-4 weeks after microwave surgery for a total of 9 cycles of treatment

Group Type: EXPERIMENTAL

PD-1 Inhibitors

Intervention Type: DRUG

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

Control group

Receive regular monitoring and follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chen Xiaoping

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaoping

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

WanGuang D Zhang

Role: STUDY_DIRECTOR

Tongji Hospital

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Wuhan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

WanGuang D Zhang

Role: CONTACT

wgzhang@tjh.tjmu.edu.cn

+8613886195965

Facility Contacts

WanGuang D Zhang

Role: primary

wgzhang@tjh.tjmu.edu.cn

+8613886195965

Other Identifiers

HOPE-01

Identifier Type: -

Identifier Source: org_study_id