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Donafenib Plus Sintilimab for Advanced HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Donafenib+sintilimab
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Donafenib, Sintilimab, TKI, PD-1 inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically
  • Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
  • Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included
  • At least one measurable lesion
  • Child-Pugh score ≤7
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and hematologic function
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Diffuse HCC
  • Macrovascular invasion involving the main trunk or inferior vena cava
  • Central nervous system metastasis
  • History of malignancy other than HCC
  • Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment
  • Uncontrolled ascites
  • History of hepatic encephalopathy
  • Patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (HAIC) for HCC
  • History of organ and cell transplantation
  • Active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab
  • Autoimmune disease or immune deficiency
  • Severe organ (heart, kidney) dysfunction

Sites / Locations

  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Donafenib+sintilimab

Arm Description

Donafenib combined with sitilimab.

Outcomes

Primary Outcome Measures

Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST).
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

Secondary Outcome Measures

Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
PFS assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Objective response rate (ORR) assessed by investigators according to mRECIST.
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
Disease control rate (DCR) assessed by investigators according to mRECIST.
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).
ORR assessed by investigators according to RECIST 1.1.
The percentage of patients who had a best overall tumor response rating of CR or PR.
DCR assessed by investigators according to RECIST 1.1.
The percentage of patients who had a tumor response rating of CR, PR, or SD.

Full Information

First Posted
December 1, 2021
Last Updated
December 4, 2021
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05162352
Brief Title
Donafenib Plus Sintilimab for Advanced HCC
Official Title
Donafenib Combined With Sintilimab for Advanced HCC: a Single-arm, Single-center, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC).
Detailed Description
This is a Phase II study to evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced HCC. 30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer [BCLC] stage C, or China liver cancer staging [CNLC] IIIa/IIIb) will be enrolled in the study. Part 1 (Safety Run-in): 6 patients will receive donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-day cycle. Part 2: patients will receive donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W. Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Donafenib, Sintilimab, TKI, PD-1 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donafenib+sintilimab
Arm Type
Experimental
Arm Description
Donafenib combined with sitilimab.
Intervention Type
Drug
Intervention Name(s)
Donafenib+sintilimab
Intervention Description
Part 1 (Safety Run-in): donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-days cycle. Part 2: donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W. Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Primary Outcome Measure Information:
Title
Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST).
Description
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Time Frame
18 months
Title
PFS assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1
Description
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time Frame
18 months
Title
Objective response rate (ORR) assessed by investigators according to mRECIST.
Description
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
Time Frame
18 months
Title
Disease control rate (DCR) assessed by investigators according to mRECIST.
Description
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).
Time Frame
18 months
Title
ORR assessed by investigators according to RECIST 1.1.
Description
The percentage of patients who had a best overall tumor response rating of CR or PR.
Time Frame
18 months
Title
DCR assessed by investigators according to RECIST 1.1.
Description
The percentage of patients who had a tumor response rating of CR, PR, or SD.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included At least one measurable lesion Child-Pugh score ≤7 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ and hematologic function Life expectancy of at least 3 months Exclusion Criteria: Diffuse HCC Macrovascular invasion involving the main trunk or inferior vena cava Central nervous system metastasis History of malignancy other than HCC Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment Uncontrolled ascites History of hepatic encephalopathy Patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (HAIC) for HCC History of organ and cell transplantation Active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab Autoimmune disease or immune deficiency Severe organ (heart, kidney) dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingyue Cai, Dr.
Phone
+86-20-34156205
Email
cai020@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Kangshun Zhu, Dr.
Phone
+86-20-34156205
Email
zhksh010@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kangshun Zhu, Dr.
Organizational Affiliation
Second Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangshun Zhu, Dr.
Phone
+86-20-34156205
Email
zhksh010@126.com
First Name & Middle Initial & Last Name & Degree
Kangshun Zhu, Dr.
First Name & Middle Initial & Last Name & Degree
Mingyue Cai, Dr.

12. IPD Sharing Statement

Learn more about this trial

Donafenib Plus Sintilimab for Advanced HCC

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