Postoperative Adjuvant Therapy of HCC Based on PD-1

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307926
• Other study ID #: Y-D202001-0289
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: August 20, 2022

Study information

• Verified date: September 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 573
• Est. completion date: August 20, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

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

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chen Xiaoping

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival	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.
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The primary outcomes of this study include the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	12months