Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma

NCT05507632 | Active Not Recruiting Phase 2

• 1 other identifier: NFEC-2022-256
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma(HCC).

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; HCC; Donafenib; Sintilimab; transarterial chemoembolisation

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) as assessed by mRECIST

  ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by mRECIST

  From date of first dose of study treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

Secondary Outcomes (5)

• Objective response rate (ORR) as assessed by RECIST 1.1

  From date of first dose of study treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

• Disease control rate (DCR)

  From date of first dose of study treatment until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

• Duration of response (DOR)

  From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)

• Progression-free survival (PFS)

  From date of first dose of study treatment to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)

• Overall survival (OS)

  From date of first dose of study treatment to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)

Study Arms (1)

single-arm

EXPERIMENTAL

All patients treatment with Donafenib plus Sintilimab in combination with TACE

Combination Product: Donafenib plus Sintilimab in combination with transarterial chemoembolisation

Interventions

Donafenib plus Sintilimab in combination with transarterial chemoembolisation COMBINATION_PRODUCT

Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE)

single-arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient voluntarily joins the study and signs an informed consent;
• Aged 18 to 75 years, both men and women;
• Clinically or pathologically confirmed Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC, not suitable for radical treatment, and no prior systemic therapy for liver cancer;
• At least one measurable lesion according to mRECIST, defined as a spiral computed tomography (CT) long diameter ≥10 mm or lymph node short diameter ≥15 mm;
• Child-Pugh score small or equal to 7 points (Child-Pugh A-B);
• Single lesion \<10 cm in greatest dimension and tumor burden \<50% of liver volume;
• Must be able to swallow tablets;
• ECOG score: 0 to 1 (according to the ECOG score classification);
• The expected survival is longer than 12 weeks;
• The laboratory parameters meets the following requirements: Absolute neutrophil count \>= 1.5 x 10\^9 / L; Platelets \>= 50 x 10\^9 / L; Hemoglobin \>= 80 g / L; serum albumin \>= 28 g / L; Thyroid stimulating hormone (TSH) \<= 1 x ULN (if abnormalities should be considered at the same time FT3, FT4 levels, patients with FT3 and FT4 levels in normal range can also be enrolled); bilirubin \<= 1.5 x ULN (within 7 days prior to the first dose); ALT \<= 5 x ULN and AST \<= 5 x ULN (within 7 days prior to the first dose); AKP \<= 2.5 x ULN; serum creatinine \<= 1.5 x ULN;
• For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Sintilimab injection.

You may not qualify if:

• Any tumor ≥ 10 cm in greatest dimension or tumor involvement ≥ 50% of the liver volume;
• Receive local treatment for HCC((e.g.,TACE, TAE, HAIC or radiotherapy); Ablation and resection are permitted if performed \>4 weeks before the first dose of study intervention;
• The patient has any active auto-immune disease or a history of auto-radioimmune disease;
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy;
• The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose \> 10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment;
• Known or suspected allergy to the investigational agents or any agent given in association with this trial;
• Known central nervous system tumors including metastatic brain disease;
• History of organ allograft;
• Ascites with clinical symptoms;
• The intrahepatic neoplasms showed diffuse changes;
• Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure \>= 140mmHg or diastolic blood pressure \>=90 mmHg);
• Suffering heart diseases with clinical symptoms or those not well controlled, such as:(1) Heart failure in NYHA class 2 or higher;(2) Unstable angina;(3) Myocardial infarction occurred within 1 year;(4) Clinically symptomatic supraventricular or ventricular arrhythmia requiring treatment or intervention;(5) Tc \> 450ms (male); QTc \> 470ms (female).
• Abnormal coagulation (INR\>2.0, PT extension time \>4s), bleeding tendency or being treated with thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin and low-molecular-weight heparin;
• Evidence of bleeding diathesis; Patients with clinically significant gastrointestinal bleeding within 3 months prior to study entry.
• Events of arterial/venous thrombosis occurring within the first 6 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

donafenib; sintilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jinzhang Chen

  Nanfang Hostipal of Southern Medical University

  STUDY DIRECTOR

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: August 15, 2022
• First Posted: August 19, 2022
• Study Start: August 18, 2022
• Primary Completion: March 26, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)