An observational study in Hepatocellular Carcinoma and RFS, sponsored by Chen Xiaoping. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Chen Xiaoping · Observational
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 573 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Chen Xiaoping is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
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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.
Exclusion Criteria:
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
Patients who received 1 TACE about a month after the operation were included in the control cohort.
Procedure: TACE
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
Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.
Disease-free survival
The primary outcomes of this study include 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
Overall Survival
The secondary outcomes of this study include overall survival
Time frame: 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]
The primary outcomes of this study include the incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
Time frame: 12months
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Chen Xiaoping