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

NCT06248554 | Recruiting

• 1 other identifier: HOPE-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Adjuvant therapy; Microwave ablation; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival

  From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months

• Adverse effects

  6 months

Study Arms (2)

PD-1 inhibitor adjuvant therapy group

EXPERIMENTAL

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

Drug: PD-1 Inhibitors

Control group

NO INTERVENTION

Receive regular monitoring and follow-up

Interventions

PD-1 Inhibitors DRUG

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

PD-1 inhibitor adjuvant therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Sites (1)

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

Wuhan, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• WanGuang D Zhang

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

WanGuang D Zhang

CONTACT

+8613886195965; wgzhang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: December 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)