Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage Hepatocellular Carcinoma Out Up-to-seven: a Multi-center Randomized Controlled Trial.

Who is this study for? Patients with BCLC B stage hepatocellular carcinoma
What treatments are being studied? HAIC+TACE+FOLFOX+cTACE or DEB-TACE+Donafenib
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

• Child-Pugh class A.

⁃ Patients with laboratory values that meet the following criteria:

∙ Hemoglobin≥90 g/L;

‣ Neutrophile granulocytes≥1.5×109/L;

‣ Platelet count≥75×109/L;

‣ Albumin≥30 g/L;

‣ Total serum bilirubin ≤ 2 times upper limits of normal;

‣ AST and ALT ≤ 5 times upper limits of normal;

‣ Serum creatinine ≤ 1.5 times upper limits of normal;

‣ Alkaline phosphatase ≤ 5 times upper limits of normal;

‣ Prothrombin time or international normalized ratio ≤ 1.5 times upper limits of normal, activated partial thromboplastin time (APTT) ≤ 1.5×ULN;

Locations
Other Locations
China
Peking University Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiaodong Wang, MD
tigat@126.com
0086-18611586227
Time Frame
Start Date: 2021-12-24
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 156
Treatments
Experimental: HAIC-TACE-Dona Group
200 mg of donafenib (consisting of two 100-mg tablets) twice daily combine with hepatic arterial infusion chemotherapy that consists of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. After 2-4 cycles of HAIC treatment, the sequential TACE therapy would be performed.
Active_comparator: TACE-Dona Group
200 mg of donafenib (consisting of two 100-mg tablets) twice daily combine with cTACE or DEB-TACE that mixed with EPI.
Related Therapeutic Areas
Sponsors
Leads: Peking University

This content was sourced from clinicaltrials.gov

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