Postoperative Adjuvant Therapy of HCC Based on PD-1

NCT ID: NCT05307926

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 573 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-08-20

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.

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.

Conditions

Hepatocellular Carcinoma; RFS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

PD-1 inhibitors

Intervention Type: 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.

TACE cohort

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

TACE

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DRUG

TACE

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

Intervention Type: PROCEDURE

Other Intervention Names

Lenvatinib

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chen Xiaoping

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaoping

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

xiaoping Dr Chen

Role: STUDY_CHAIR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Countries

China

Other Identifiers

Y-D202001-0289

Identifier Type: -

Identifier Source: org_study_id