Clinical trial NCT05307926: Postoperative Adjuvant Therapy of HCC Based on PD-1
Official title: PD-1-based Adjuvant Therapy in High-risk Hepatocellular Carcinoma Patients After Curative Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
RFS
Keywords: PD-1
Disease-free survival rate
adjuvant therapy
Lenvatinib
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 573
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Disease-free survival
timeFrame: 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:
measure: Overall Survival
timeFrame: From date of inclued in this research until the date of death from any cause, assessed up to 60 months.
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 12months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: xiaoping Dr Chen
role: STUDY_CHAIR
References: