A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection

Sponsor

Tongji Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06089382

Collaborator

(none)

104

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Sintilimab Drug: Lenvatinib Procedure: Transarterial Chemoembolization (TACE)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III Trial of Sintilimab Plus Lenvatinib in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sintilimab Plus Lenvatinib	Drug: Sintilimab IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence） Other Names: IBI 308 Drug: Lenvatinib 8mg orally once a day for 1 year Other Names: LENVIMA
Active Comparator: TACE(one cycle) + active surveillance	Procedure: Transarterial Chemoembolization (TACE) One cycle of TACE postoperatively

Arm

Intervention/Treatment

Experimental: Sintilimab Plus Lenvatinib

Drug: Sintilimab

IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence）

Other Names:

IBI 308

Drug: Lenvatinib

8mg orally once a day for 1 year

Other Names:

LENVIMA

Active Comparator: TACE(one cycle) + active surveillance

Procedure: Transarterial Chemoembolization (TACE)

One cycle of TACE postoperatively

Outcome Measures

Primary Outcome Measures

Recurrence-Free Survival (RFS) [Randomization up to approximately 36 months]
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).

Secondary Outcome Measures

RFS Rate at 12 and 24 Months [up to 24 months]
Overall Survival (OS) [Randomization up to approximately 36 months]
Adverse events (AEs) [Randomization up to approximately 36 months]
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Quality of Life (QoL) Scale Score [Baseline up to 36 months]
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score
Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score [Baseline up to 36 months]
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with a histopathological diagnosis of HCC
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:

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
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