Clinical trial · Observational

Adjuvant Anti-PD-1 Therapy in Resected Hepatocellular Carcinoma

Efficacy of Postoperative Adjuvant PD-1 Inhibitors Guided by a Deep Learning Model: a Multicenter, Prospective Cohort Study

NCT07379489CI-TRIAL-00102067not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Adjuvant Therapy	—	UNRESOLVED	—
HCC	—	UNRESOLVED	—
Immune Checkpoint Inhibitor	—	UNRESOLVED	—
Recurrence	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
PD-1 Inhibitors	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Active surveillance cohort
label
Adjuvant PD-1 inhibitor cohort
interventionNames
1. Drug: PD-1 Inhibitors

Primary outcomes (1)

measure
Disease free survival
timeFrame
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)

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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

References

Publications (0)

Data not yet available

No reference posted for this study.