NCT05344924

Brief Summary

The purpose of this multicenter, dual-cohort, prospective real-world study is to explore the efficacy and safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients.

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
109

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2022

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

April 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

April 18, 2022

Last Update Submit

December 28, 2022

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaTransarterial chemoembolizationPenpulimabAnlotinib

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    Time from initiation of either combination therapy to tumor progression according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria or death from any cause.

    2 years

Secondary Outcomes (3)

  • Objective response rate(ORR)

    2 years

  • Overall survival (OS)

    up to 5 years

  • Adverse effects

    2 years

Study Arms (2)

Cohort I（TACE-A-A Cohort）

EXPERIMENTAL

Patients will receive TACE as needed; penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment.

Drug: TACE+penpulimab+anlotinib vs. penpulimab+anlotinib

Cohort II (A-A Cohort)

EXPERIMENTAL

Patients will receive penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment.

Drug: TACE+penpulimab+anlotinib vs. penpulimab+anlotinib

Interventions

TACE+penpulimab+anlotinib vs. penpulimab+anlotinibDRUG

Patients will receive TACE as needed; penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment.

Also known as: The combination of penpulimab+anlotinib with or without TACE
Cohort II (A-A Cohort)Cohort I（TACE-A-A Cohort）

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically or clinically diagnosed HCC patients;
  • Age of 18-80;
  • Barcelona Clinic Liver Cancer (BCLC) stage C (ie, China Liver Cancer Staging (CNLC) stage III);
  • with expect survival ≥ 3 months;
  • with obtained informed consent;
  • will receive penpulimab and anlotinib combined with or without TACE.

You may not qualify if:

  • Contraindications of penpulimab and anlotinib;
  • Child-Pugh C;
  • Key information (such as imaging, liver function, Eastern Cooperative Oncology Group(ECOG) score, etc.) missing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital Affiliated to Southeast University

Nanjing, Jiangsu, 210009, 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 Officials

  • Gao-Jun Teng, MD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai-Dong Zhu, MD

CONTACT

86-25-83262224zhuhaidong9509@163.com

Ri Li, MS

CONTACT

86-25-83262224qmjk_xsj@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients in cohort I will receive TACE combined with penpulimab and anlotinib (TACE-A-A Cohort), and patients in cohort II will just receive penpulimab and anlotinib (A-A Cohort).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Zhongda Hospital

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 25, 2022

Study Start

October 12, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2024

Last Updated

December 29, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)