NCT06089382

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at below P25 for phase_3 hepatocellular-carcinoma

Timeline
6mo left

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

October 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 13, 2023

Last Update Submit

October 17, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Programmed Cell Death 1lysine kinase inhibitorImmunotherapyAdjuvantHepatocellular CarcinomaPortal vein tumor thrombus,PVTT

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 approximately 36 months

Secondary Outcomes (5)

  • 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

  • Quality of Life (QoL) Scale Score

    Baseline up to 36 months

  • Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score

    Baseline up to 36 months

Study Arms (2)

Sintilimab Plus Lenvatinib

EXPERIMENTAL
Drug: SintilimabDrug: Lenvatinib

TACE(one cycle) + active surveillance

ACTIVE COMPARATOR
Procedure: Transarterial Chemoembolization (TACE)

Interventions

SintilimabDRUG

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

Also known as: IBI 308
Sintilimab Plus Lenvatinib
LenvatinibDRUG

8mg orally once a day for 1 year

Also known as: LENVIMA
Sintilimab Plus Lenvatinib
Transarterial Chemoembolization (TACE)PROCEDURE

One cycle of TACE postoperatively

TACE(one cycle) + active surveillance

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

sintilimablenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Xiaoping Chen, Prodessor

CONTACT

02783665213chenxpchenxp@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

November 1, 2023

Primary Completion

November 1, 2024

Study Completion (Estimated)

November 1, 2026

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

CN(1)