NCT04718909

Brief Summary

This study is conducted to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for patients with unresectable hepatocellullar carcinoma (HCC).

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
166

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2021

Typical duration for phase_2

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

Study Start

First participant enrolled

January 9, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

2.5 years

First QC Date

January 20, 2021

Last Update Submit

November 8, 2022

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular carcinomaRegorafenibSintilimabSecond-line treatment

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS) assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1 and immune-related RECIST (irRECIST)

    The time from date of randomization until the first occurrence of disease progression or death due to any cause, whichever occurs first.

    24 months

Secondary Outcomes (9)

  • Adverse Events (AEs)

    24 months

  • Overall survival (OS)

    24 months

  • Time to Progression (TTP) assessed by investigators according to RECIST 1.1 and irRECIST

    24 months

  • Objective response rate (ORR) assessed by investigators according to RECIST 1.1 and irRECIST.

    24 months

  • Disease control rate (DCR) assessed by investigators according to RECIST 1.1 and irRECIST

    24 months

  • +4 more secondary outcomes

Study Arms (2)

Regorafenib + sintilimab

EXPERIMENTAL

Regorafenib combined with sintilimab.

Drug: Regorafenib + sintilimab

Regorafenib

ACTIVE COMPARATOR

Regorafenib alone.

Drug: Regorafenib

Interventions

Regorafenib + sintilimabDRUG

Regorafenib: 160 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off). Sintilimab: 200mg i.v. q3w.

Regorafenib + sintilimab
RegorafenibDRUG

160 mg p.o. qd for 3 weeks of every 4 week cycle.

Regorafenib

Eligibility Criteria

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

You may qualify if:

  • Patients with unresectable HCC confirmed by histology/cytology or clinically.
  • Failure to prior sorafenib or lenvatinib treatment, or intolerance to sorafenib or lenvatinib.
  • For patients who cannot tolerant to sorafenib or lenvatinib, the AEs must resolve to ≤ grade 1 (NCI-CTCAE v5.0) before randomization.
  • Child-Pugh class A.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
  • At least one measurable lesion.
  • Adequate organ and hematologic function.
  • Life expectancy of at least 3 months.
  • For women of childbearing potential and for men: agreement to remain abstinent.

You may not qualify if:

  • Diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Diffuse HCC.
  • Portal vein tumor thrombus (PVTT) involves the main trunk and contralateral branch or upper mesenteric vein.
  • Inferior vena cava tumor thrombus.
  • Metastatic disease that involves major airways or blood vessels.
  • Symptomatic, untreated or progressing central nervous system metastasis.
  • History of hepatic encephalopathy
  • History of organ and stem cell transplantation
  • Uncontrolled ascites, hydrothorax or pericardial effusion
  • Patients who receive systemic therapy except for sorafenib and lenvatinib within 4 weeks before randomization, including other molecular targeted drugs, chemotherapy (including hepatic arterial infusion chemotherapy), immunotherapy, and herbal therapy or traditional Chinese medicine with anti-cancer activity.
  • Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment.
  • Untreated or incompletely treated esophageal and/or gastric varices with high-risk for bleeding.
  • History of venous thromboembolism, but implantable i.v. ports, catheter-derived thrombosis, superficial venous thrombosis, or thrombosis effectively treated by regular anticoagulant therapy are excluded.
  • Use of anticoagulants which need monitoring of international normalized ratio.
  • Patients unable to swallow oral medications; Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that may affect the absorption of regorafenib.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

regorafenibsintilimab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kangshun Zhu, Dr.

    Second Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 22, 2021

Study Start

January 9, 2021

Primary Completion

July 8, 2023

Study Completion

December 31, 2023

Last Updated

November 10, 2022

Record last verified: 2022-11

Locations

CN(1)