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Trial Title:
Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma
NCT ID:
NCT05507632
Condition:
Unresectable Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
hepatocellular carcinoma
HCC
Donafenib
Sintilimab
transarterial chemoembolisation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Donafenib plus Sintilimab in combination with transarterial chemoembolisation
Description:
Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE)
Arm group label:
single-arm
Summary:
To evaluate the efficacy and safety of Donafenib plus Sintilimab in combination with
transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular
carcinoma(HCC).
Detailed description:
Transarterial chemoembolisation (TACE) was effective and safe for hepatocellular
carcinoma. Donafenib was better than sorafenib in overall survival in untreated advanced
hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was
effective and tolerable in patients with advanced hepatocellular carcinoma. No study has
evaluated TACE plus donafenib and sintilimab. Thus, the investigators carried out this
prospective, single-arm study to find out it.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The patient voluntarily joins the study and signs an informed consent;
- Aged 18 to 75 years, both men and women;
- Clinical diagnosis of BCLC B(4 <=tumor numbers<=10 ) or C-stage hepatocellular
carcinoma, no further first-line treatment;
- At least one intrahepatic evaluable tumor existed, intrahepatic tumor is the primary
tumor burden;
- Child-Pugh score small or equal to 7 points (Child-Pugh A-B);
- The maximum liver tumor diameter < 7cm, All lesions in the liver could be treated
with stage 1 or 2 TACE;
- 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 (no blood components and
cell growth factors are allowed within 14 days before the first dose):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 <= 3 x ULN and AST <= 3 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.
Exclusion Criteria:
- The maximum liver tumor diameter >= 10 cm, tumor numbers > 10;
- Receive local treatment for HCC((e.g.,TACE, TAE, HAIC or radiotherapy); If the
treatment of ablation and/or resection > 4 weeks is permitted;
- 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;
- Known history of hereditary or acquired bleeding and thrombotic tendencies (e.g.,
hemophiliacs, coagulopathy, thrombocytopenia, etc.);
- Had intestinal obstruction and/or had clinical signs or symptoms of GI obstruction
within 6 months prior to the start of study treatment, including incomplete
obstruction related to pre-existing conditions or requiring routine parenteral
hydration, parenteral nutrition, or tube feeding;
- Urine routine indicates that urine protein >= ++ and 24-hour urine protein amount >
1.0g was confirmed;
- The patient has active infection, unexplained fever (>=38.5 degree C) within 3 days
before administration, or baseline white blood cell count > 15 x 10^9/L;
- Patients with congenital or acquired immunodeficiency (such as HIV-infected
patients);
- HBV-DNA > 2000 IU/ml (or 10^4 copies/ml); or HCV-RNA > 10^3 copies/ml; or HBsAg+ and
anti-HCV antibody positive patients;
- The patient has had other malignant tumors in the past 3 years or at the same time
(except for cured skin basal cell carcinoma and cervical carcinoma in situ);
- Palliative radiotherapy for non-target lesions to control symptoms is permitted and
must be completed at least 2 weeks prior to the start of the study treatment. The
adverse events caused by radiotherapy have not recovered to <= CTCAE 1;
- Patients have previously received other anti-PD-1 antibody therapy or other
immunotherapy against PD-1/PD-L1, or have received apatinib before;
- Inoculation of a live vaccine within less than 4 weeks prior to study or possibly
during the study period;
- Pregnant or lactating women, or women of childbearing age who are unwilling to take
contraceptive measures;
- According to the investigators, the patient has other factors that may affect the
results of the study or lead to the termination of the study, such as alcohol abuse,
drug abuse, other serious diseases (including mental illness) requiring combined
treatment, and serious laboratory tests, abnormalities, accompanied by factors such
as family or society, which may affect the safety of enrolled patients.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 15, 2022
Completion date:
December 21, 2026
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05507632
