Postoperative Adjuvant Therapy of HCC Based on PD-1

NCT05307926 | Completed

• 1 other identifier: Y-D202001-0289
• Study Type: observational
• Target: 573
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; RFS

Keywords

PD-1; Disease-free survival rate; adjuvant therapy; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  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 Outcomes (2)

• 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]

  12months

Study Arms (2)

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

TACE cohort

Patients who received 1 TACE about a month after the operation were included in the control cohort.

Procedure: TACE

Interventions

PD-1 inhibitors DRUG

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.

Also known as: Lenvatinib

PD-1 based therapy cohort

TACE PROCEDURE

Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.

TACE cohort

Eligibility Criteria

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

You may qualify if:

• \. In patients with HCC who received R0 resection, there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain
• \. 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
• \. Aged18-75
• \. Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
• \. Child-Pugh grade A or B
• \. The patient knows, and informed consent was obtained

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 surgery-related complications
• \. Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
• \. Inability or refusal to comply with the treatment and monitoring

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cancer tissues were collected after surgery. The genetic differences between the responding and non-responding lesions to PD-1-based adjuvant therapy were compared using transcriptomic and proteomic analyses.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immune Checkpoint Inhibitors; lenvatinib

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

• xiaoping Dr Chen

  Tongji Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 1, 2022
• Study Start: February 1, 2019
• Primary Completion: July 30, 2022
• Study Completion: August 20, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

CN (1)