NCT04806243

Brief Summary

To investigate the efficacy and safety of carelizumab combined with regorafenib in second-line treatment for patients with primary hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started May 2021

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 4, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

June 30, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

March 4, 2021

Last Update Submit

June 28, 2021

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • os（overall survival）

    overall survival

    21 days

Secondary Outcomes (5)

  • PFS（progression-free survival）

    21 days

  • TTP（Time-To-Progression）

    21 days

  • ORR（Overall Response Rate）

    21 days

  • DCR（disease control rate）

    21 days

  • DoR

    21 days

Study Arms (1)

Carelizumab Combined With Regorafenib arm

EXPERIMENTAL
Drug: Regorafenib Pill&Camrelizumab

Interventions

Regorafenib Pill&CamrelizumabDRUG

Regorafenib，80 mg，QD，Q3w Camrelizumab，200 mg，IV，Q3w

Carelizumab Combined With Regorafenib arm

Eligibility Criteria

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

You may qualify if:

  • Not convenient to disclose

You may not qualify if:

  • Not convenient to disclose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 19, 2021

Study Start

May 6, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

June 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)