Status:
COMPLETED
Postoperative Adjuvant Therapy of HCC Based on PD-1
Lead Sponsor:
Chen Xiaoping
Conditions:
Hepatocellular Carcinoma
RFS
Eligibility:
All Genders
18-75 years
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 patie...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 20 2022
Estimated Enrollment :
573 Patients enrolled
Trial Details
Trial ID
NCT05307926
Start Date
February 1 2019
End Date
August 20 2022
Last Update
September 7 2022
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030