Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

NCT06089369 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: Adjuvant-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Programmed Cell Death 1; Checkpoint Inhibitor; Immunotherapy; Adjuvant; Hepatocellular Carcinoma; Microvascular Invasion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• RFS Rate at 12 ,24 , 36 , 60 Months

  Randomization up to 60 months

• Overall Survival (OS)

  Randomization up to 60 months

• Adverse events

  Baseline up to 60 months

• Quality of Life (QoL) Scale Score

  Baseline up to 60 months

Study Arms (3)

Sintilimab for six months group (9 cycles)

EXPERIMENTAL

Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 9 cycles or until disease recurrence or intolerable adverse effects occurred.

Drug: Sintilimab (9 cycles)

Sintilimab for one year group (18 cycles)

EXPERIMENTAL

Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 18 cycles or until disease recurrence or intolerable adverse effects occurred.

Drug: Sintilimab (18 cycles)

Active surveillance

ACTIVE COMPARATOR

Patients are closely monitored postoperatively.

Other: Active surveillance

Interventions

Sintilimab (9 cycles) DRUG

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

Also known as: IBI 308

Sintilimab for six months group (9 cycles)

Sintilimab (18 cycles) DRUG

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

Also known as: IBI 308

Sintilimab for one year group (18 cycles)

Active surveillance OTHER

Active surveillance

Active surveillance

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimab; Watchful Waiting

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Xiaoping Chen, Prodessor

CONTACT

02783665213; chenxpchenxp@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 18, 2023
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)