Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

Hepatocellular Carcinoma Clinical Trial

Official title:

Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089369
• Other study ID #: Adjuvant-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: Xiaoping Chen, Prodessor
• Phone: 02783665213
• Email: chenxpchenxp[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: November 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sintilimab (9 cycles)
IV infusion of Sintilimab (200mg intravenously every 3 weeks for a total of 9 cycles)
• Sintilimab (18 cycles)
IV infusion of Sintilimab (200mg intravenously every 3 weeks for a total of 18 cycles)

Other:
• Active surveillance
Active surveillance

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-Free Survival (RFS)	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).	Randomization up to 60 months
Secondary	RFS Rate at 12 ,24 , 36 , 60 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).	Randomization up to 60 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death from any cause	Randomization up to 60 months
Secondary	Adverse events	The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0	Baseline up to 60 months
Secondary	Quality of Life (QoL) Scale Score	Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score	Baseline up to 60 months