Postoperative Adjuvant Therapy of HCC Based on PD-1

September 5, 2022 updated by: Chen Xiaoping

PD-1-based Adjuvant Therapy in High-risk Hepatocellular Carcinoma Patients After Curative Resection

For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative recurrence of HCC requires further study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We conducted a prospective cohort study comparing the efficacy of PD-1-based adjuvant therapy and transarterial chemoembolization in patients with high-risk factors for recurrence undergoing radical surgery. After surgery, patients received the appropriate adjuvant therapy according to the type of high-risk recurrence factor. Patients with high-risk factors for recurrence who received PD-1-based adjuvant therapy were included in the exposure cohort; patients with high-risk factors for recurrence who received 1 TACE adjuvant therapy were included in the control cohort. The primary endpoint of this study was disease-free survival, and the overall survival and adverse events were considered as the second endpoint.

Study Type

Observational

Enrollment (Actual)

573

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients had HCC and underwent radical liver resection (R0), postoperative pathology confirmed that they were associated with high-risk factors for recurrence. Depending on the type of recurrence factor, they were treated with appropriate postoperative adjuvant therapy. Patients who received PD-1-based adjuvant therapy or TACE adjuvant therapy were included in this prospective cohort study.

Description

Inclusion Criteria:

  • 1. In patients with HCC who received R0 resection, there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain
  • 2. Patients with high-risk factors for tumor recurrence (tumor diameter ≥ 5cm, multiple tumors, tumor rupture, AFP ≥ 400 ng/dl, microvascular invasion, portal vein thrombosis, and poorly differentiated) and received PD-1-based adjuvant therapy or TACE adjuvant therapy after the surgery
  • 3. Aged18-75
  • 4. Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
  • 5. Child-Pugh grade A or B
  • 6. The patient knows, and informed consent was obtained

Exclusion Criteria:

  • 1. Any history of other malignant tumors or recurrent HCC
  • 2. Any preoperative treatment for HCC including local and systemic therapy
  • 3. Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
  • 4. Any persistent serious surgery-related complications
  • 5. Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
  • 6. Inability or refusal to comply with the treatment and monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD-1 based therapy cohort
Patients who received PD-1 inhibitors or PD-1 inhibitors plus Lenvatinib therapy 2-4 weeks after the operation were included in the PD-1-based therapy cohort.
Drug: PD-1 inhibitors
For patients with PVTT, they received adjuvant therapy of PD1 (200mg intravenously every 3 weeks for a total of 18cycles) plus Lenvatinib (8mg orally once a day for 1 year) 2-4 weeks after surgery; for patients with other high-risk factors for recurrence, they PD-1(200mg intravenously every 3 weeks for a total of 9cycles) monotherapy 2-4 weeks after surgery.
Other Names:
  • Lenvatinib
TACE cohort
Patients who received 1 TACE about a month after the operation were included in the control cohort.
Procedure: TACE
Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: From date of inclued 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
The primary outcomes of this study include disease-free survival
From date of inclued 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of inclued in this research until the date of death from any cause, assessed up to 60 months.
The secondary outcomes of this study include overall survival
From date of inclued in this research until the date of death from any cause, assessed up to 60 months.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 12months
The primary outcomes of this study include the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Xiaoping

Investigators

  • Study Chair: xiaoping Dr Chen, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

August 20, 2022

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y-D202001-0289

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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