Adjuvant Anti-PD-1 Therapy in Resected Hepatocellular Carcinoma

NCT07379489 | Not Yet Recruiting

• 1 other identifier: MLbased-adjuvant01
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Early hepatocellular carcinoma (HCC) recurrence (driven by residual tumors) and late recurrence (driven by de novo tumors) exhibit distinct biological behaviors, suggesting differential therapeutic vulnerabilities. The beneficiaries of adjuvant PD-1 inhibitors (aPD-1) and their efficacy across these temporally divergent recurrence patterns remains unestablished.

Conditions

HCC; Adjuvant Therapy; Recurrence; Immune Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 96months.

Secondary Outcomes (1)

• Overall survival

  From date of enrollment until the date of death from any cause, assessed up to 96 months.

Study Arms (2)

Active surveillance cohort

Adjuvant PD-1 inhibitor cohort

Drug: PD-1 Inhibitors

Interventions

PD-1 Inhibitors DRUG

Patients in the adjuvant cohort received at least one cycle of PD-1 inhibitors.

Adjuvant PD-1 inhibitor cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population was patients with hepatocellular carcinoma who were undergoing curative surgery as initial treatment and who were receiving active surveillance or adjuvant PD-1 inhibitors postoperatively.

You may qualify if:

• Aged between 18 and 75;
• achieved complete tumor resection;
• histological verification of HCC;
• liver function classified as Child-Pugh grade A or B;
• No other serious systemic disease or organ dysfunction.

You may not qualify if:

• history of other malignancies or recurrent HCC;
• extrahepatic metastasis;
• prior treatments for HCC;
• ongoing severe postoperative complications;
• mixed or other types of liver cancer;
• received other adjuvant therapy.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Recurrence

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Wanguang Zhang, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP