To hear about similar clinical trials, please enter your email below
Trial Title:
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
NCT ID:
NCT06089369
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Programmed Cell Death 1
Checkpoint Inhibitor
Immunotherapy
Adjuvant
Hepatocellular Carcinoma
Microvascular Invasion
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab (9 cycles)
Description:
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 9 cycles）
Arm group label:
Sintilimab for six months group (9 cycles)
Other name:
IBI 308
Intervention type:
Drug
Intervention name:
Sintilimab (18 cycles)
Description:
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles）
Arm group label:
Sintilimab for one year group (18 cycles)
Other name:
IBI 308
Intervention type:
Other
Intervention name:
Active surveillance
Description:
Active surveillance
Arm group label:
Active surveillance
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Start date:
June 1, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06089369
