Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled… (NCT05171166) | Clinical Trial Compass
TerminatedPhase 2/3
Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial.
Stopped: Difficult to enroll participants
China18 participantsStarted 2021-12-24
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of the combination therapy with HAIC-TACE and donafenib compared to TACE plus donafenib in patients with BCLC B stage unresectable hepatocellular carcinoma (HCC) out of up-to-seven criteria.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures.
✓. Age and gender: \>18 years old and≤75 years old, both men and women.
✓. All subjects must have Hepatocellular Carcinoma confirmed by pathological or clinical diagnosis.
✓. Subjects are not suitable for radical resection or radical ablative therapy.
✓. BCLC B based on Barcelona Clinic Liver Cancer staging system, and the lesions in the liver exceed up to 7 criteria, the number of tumors + the maximum diameter of tumors \> 7.
✓. Patients with viable and measurable target lesion per mRECIST.
✓. Patients who are expected to live more than 3 months.
✓. ECOG PS 0-1.
Exclusion criteria
✕. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology.
✕. History of malignant tumor, excluding the following cases:
✕. Malignant tumor that was curatively treated more than 5 years prior to study entry and has not recurred since then;
✕. Successful radical resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, preinvasive cervix carcinoma, and other preinvasive cancers.
What they're measuring
1
Progression-free survival
Timeframe: From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.