Clinical trial NCT06089369: Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
Official title: Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: Programmed Cell Death 1
Checkpoint Inhibitor
Immunotherapy
Adjuvant
Hepatocellular Carcinoma
Microvascular Invasion
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.

Detailed description: This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.

Eligibility criteria: Inclusion Criteria:

* Subjects with a histopathological diagnosis of HCC
* Undergone a curative resection
* Pathologically confirmed HCC with microvascular invasion (MVI)
* Aged 18-75 years
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* Absence of major macrovascular invasion
* No extrahepatic spread
* Full recovery from Curative resection within 4 weeks prior to randomization
* Child-Pugh: Grade A or B(7)
* ECOG-PS score: 0 or 1
* Subjects with HCV- RNA (+) must receive antiviral therapy
* Adequate organ function

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
* Any preoperative treatment for HCC including local and systemic therapy
* Have received more than 1 cycle of adjuvant TACE following surgical resection
* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* Cardiac clinical symptom or cardiovascular disease that is not well controlled
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Inability or refusal to comply with the treatment and monitoring

Primary outcomes:
measure: Recurrence-Free Survival (RFS)
timeFrame: Randomization up to 60 months
Secondary outcomes:
measure: RFS Rate at 12 ,24 , 36 , 60 Months
timeFrame: Randomization up to 60 months
measure: Overall Survival (OS)
timeFrame: Randomization up to 60 months
measure: Adverse events
timeFrame: Baseline up to 60 months
measure: Quality of Life (QoL) Scale Score
timeFrame: Baseline up to 60 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: