Actively Recruiting
Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
Led by Anhui Provincial Hospital · Updated on 2024-07-12
45
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, single arm study to evaluate the efficacy and safety of donafenib in combination with envafolimab treatment in patients with high risk of recurrent hepatocellular carcinoma after radical surgery.
CONDITIONS
Official Title
Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, male or female
- Voluntary enrollment with signed informed consent and good compliance
- Primary hepatocellular carcinoma confirmed by postoperative pathology with negative margins
- Presence of high-risk factors for recurrence: tumor size 65.0 cm with microvascular invasion, three or more tumors, or portal vein cancer thrombus (vp1 or vp2 type)
- No recurrence or metastasis confirmed by imaging 3-7 weeks after surgery
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Child-Pugh score of 7 or less
- No prior anti-tumor therapy except antiviral treatment
- No extra-hepatic or lymph node metastases
- Routine laboratory tests within normal limits including blood counts, liver and kidney function, and coagulation
- No blood transfusions or blood products within 14 days prior to testing
You will not qualify if you...
- Presence of fibroplaque-containing hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other tumor components
- Positive surgical margin (R1 resection), lymph node metastasis, or extrahepatic metastasis
- History or current diagnosis of malignancies other than hepatocellular carcinoma
- History of hepatic encephalopathy or liver transplantation
- Known allergy to envafolimab or donafenib
- Poorly controlled postoperative pleural, abdominal, or pericardial effusion
- Prior anti-tumor therapy except antiviral treatment
- History of interstitial lung disease or non-infectious pneumonia
- Active or past autoimmune diseases requiring treatment, excluding some well-controlled asthma or vitiligo
- Use of immunosuppressive or systemic steroids exceeding 10 mg/day prednisone or equivalent within 2 weeks prior to enrollment
- Serious infection requiring hospitalization within 4 weeks prior to treatment
- Recent acute cardiovascular events within 1 month or poorly controlled cardiovascular disease
- Severe cardiac insufficiency (NYHA class III-IV) or left ventricular ejection fraction below 50%
- Uncontrolled hypertension or hypertensive crisis
- Gastrointestinal bleeding risks including active ulcers or history of bleeding within 2 months
- Abnormal coagulation or bleeding tendency
- Recent major surgery, trauma, fractures, or unhealed wounds within 4 weeks
- Immune deficiency conditions or active hepatitis exceeding normal viral load limits
- History of substance abuse or uncontrolled mental illness
- Serious concurrent illnesses that pose safety risks or interfere with study completion
- Pregnant or breastfeeding women, or women of childbearing potential not using contraception
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
No.2 People's Hospital of Fuyang city
Fuyang, Anhui, China, 236015
Actively Recruiting
2
Anhui province hospital
Hefei, Anhui, China, 230000
Actively Recruiting
Research Team
L
Lianxin Liu
CONTACT
J
Ji-Zhou Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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