NCT06285019

Brief Summary

This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

February 21, 2024

Last Update Submit

February 22, 2024

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • objective response rate (ORR)

    ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. and mRECIST

    24 months

Secondary Outcomes (6)

  • disease control rate (DCR)

    24 months

  • Progression-Free Survival (PFS)

    24 months

  • Time to progression (TTP)

    24 months

  • Duration of response (DOR)

    24 months

  • overall survival (OS)

    24 months

  • +1 more secondary outcomes

Study Arms (1)

Combination therapy

EXPERIMENTAL

TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar

Procedure: TOMOX-HAICDrug: SintilimabDrug: Bevacizumab

Interventions

TOMOX-HAICPROCEDURE

Oxaliplatin 85mg/m\^2 plus Raltitrexed 3mg/m\^2, 21 days for a cycle

Combination therapy
SintilimabDRUG

200mg, ivgtt, d1, 21 days for a cycle

Combination therapy
BevacizumabDRUG

7.5mg/kg, ivgtt, d1, 21 days for a cycle

Combination therapy

Eligibility Criteria

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

You may qualify if:

  • Be willing and able to provide written informed consent/assent for the trial.
  • Males or unpregnant females who age ≥ 18 years, ≤75 years.
  • The investigator believes the patient is capable of complying with the study protocol.
  • Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma.
  • is not a candidate for radical surgery
  • not received previous systemic treatment
  • patients must have at least one measurable lesion (RECIST 1.1)
  • ECOG PS：0-1, 14 days before enrollment
  • Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment

You may not qualify if:

  • Prior history of other malignant tumors
  • Current or prior immunodeficiency disorders or autoimmune diseases
  • Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding
  • Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200062, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimabBevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Lu Wang

CONTACT

+86-18121299357cms024mm@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Hepatobiliary Surgery

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 29, 2024

Study Start

December 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

CN(1)