Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular C… (NCT05507632) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma
China48 participantsStarted 2022-08-18
Plain-language summary
To evaluate the efficacy and safety of Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma(HCC).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) as assessed by mRECIST
Timeframe: 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)
Trial details
NCT IDNCT05507632
SponsorNanfang Hospital, Southern Medical University