A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
NCT ID: NCT06089382
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
104 participants
INTERVENTIONAL
2023-11-01
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sintilimab Plus Lenvatinib
Sintilimab
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence）
Lenvatinib
8mg orally once a day for 1 year
TACE(one cycle) + active surveillance
Transarterial Chemoembolization (TACE)
One cycle of TACE postoperatively
Interventions
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Sintilimab
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence）
Lenvatinib
8mg orally once a day for 1 year
Transarterial Chemoembolization (TACE)
One cycle of TACE postoperatively
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergone a curative resection
* Pathologically confirmed HCC with portal vein tumor thrombus (PVTT)
* Aged 18-75 years
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* 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
* Adequate organ function
Exclusion Criteria
* 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
* Active or history of autoimmune disease
* 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
18 Years
75 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Chen Xiaoping
Professor
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Other Identifiers
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Adjuvant-02
Identifier Type: -
Identifier Source: org_study_id
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