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New treatment option for Hepatocellular Carcinoma
Official title Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
ClinicalTrials.gov ID: NCT06498622
What this study is testing
What is Donafenib + Envafolimab?
Donafenib + Envafolimab is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 18-80 years old, male and female.
- people voluntarily enrolled in this study and signed the informed consent, good compliance and co-operated with the follow-up.
- Primary hepatocellular carcinoma with postoperative histopathological diagnosis of HCC and negative margins.
- Presence of any of the following high-risk factors for recurrence: ① tumor size ≥5.0cm combined with microvascular invasion; ② number of tumors ≥3; ③...
- No recurrence of metastasis confirmed by imaging examination 3-7 weeks after surgery.
You likely can't join if
- Previous histologically/cytologically confirmed fibroplaque-containing hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma...
- Histologically confirmed positive resection margin (R1 resection), presence of lymph node metastasis or extrahepatic metastasis.
- Previous or current malignancy other than hepatocellular carcinoma.
- History of hepatic encephalopathy or history of liver transplantation.
- Previous history of allergy to any component of the test drug: Envafolimab monoclonal antibody, donafini.
- people with poorly controlled persistent postoperative pleural, abdominal or pericardial effusion.
See the full eligibility criteria
- 18-80 years old, male and female.
- people voluntarily enrolled in this study and signed the informed consent, good compliance and co-operated with the follow-up.
- Primary hepatocellular carcinoma with postoperative histopathological diagnosis of HCC and negative margins.
- Presence of any of the following high-risk factors for recurrence: ① tumor size ≥5.0cm combined with microvascular invasion; ② number of tumors ≥3; ③ presence of portal vein cancer thrombus (vp1 or vp2 type).
- No recurrence of metastasis confirmed by imaging examination 3-7 weeks after surgery.
- ECOG score of 0-1.
- Expected survival ≥ 3 months.
- Child-Pugh score ≤ 7.
- people with no previous antitumour therapy (except antiviral therapy)
- No extra-hepatic metastases or lymph node metastases.
- No significant abnormality in routine laboratory tests (blood test, liver and kidney function, coagulation function, etc.): (1) Criteria for routine blood tests need to be met (no blood and blood products transfusion...
- Previous histologically/cytologically confirmed fibroplaque-containing hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
- Histologically confirmed positive resection margin (R1 resection), presence of lymph node metastasis or extrahepatic metastasis.
- Previous or current malignancy other than hepatocellular carcinoma.
- History of hepatic encephalopathy or history of liver transplantation.
- Previous history of allergy to any component of the test drug: Envafolimab monoclonal antibody, donafini.
- people with poorly controlled persistent postoperative pleural, abdominal or pericardial effusion.
- Previous antitumour therapy (except antiviral therapy).
- History of interstitial lung disease (except radiation pneumonitis not treated with hormones), non-infectious pneumonia.
- Presence of any active autoimmune disease or history of autoimmune disease in the subject (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis...
- people who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose \>10mg/day prednisone or other equipotent hormone) and continue to use it within 2 weeks prior to...
- A serious infection (CTCAE \> grade 2) such as severe pneumonia, bacteraemia, or infectious co-morbidities requiring hospitalisation has occurred 4 weeks prior to the first use of study drug.
- people who have experienced acute cardiovascular disease such as acute cerebral infarction, acute coronary syndrome, etc. within 1 month, with cardiovascular clinical symptoms or disease not well controlled.
- According to NYHA standard, grade III to IV cardiac insufficiency, or cardiac ultrasound examination suggests that the left ventricular ejection fraction (LVEF) \<50%
- Uncontrollable hypertension with treated systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg, hypertensive crisis or history of hypertensive encephalopathy
- Patients with a definite tendency to gastrointestinal bleeding, including the following: patients with locally active ulcerative lesions and fecal occult blood {(++) may not be enrolled} those with a history of black...
- Those with abnormal coagulation function (INR\>1.5 APTT\>1.5 ULN) and bleeding tendency.
- Prolonged unhealed wounds or fractures major surgical procedures or severe traumatic injuries, fractures or ulcers within 4 weeks.
- people with congenital or acquired immune deficiency (e.g., HIV-infected individuals), or active hepatitis (Hepatitis B reference: HBV DNA test value exceeds the upper limit of normal Hepatitis C reference: HCV viral...
- Patients with a history of psychotropic substance abuse that cannot be stopped or patients with mental disorders.
- Patients with concomitant illnesses that, in the investigator's judgement, are a serious hazard to patient safety or interfere with the patient's ability to complete the study.
- Pregnant women, lactating women, and women of childbearing age who are not using adequate contraception.
- In the judgement of the investigator, Patients who are not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Fuyang, Anhui, China
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuyang, Anhui, China; Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.