Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma After Radical Surgery With Donafenib in Combination With Envafolimab: a Prospective, Multicentre, Single-arm Phase II Clinical Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 18-80 years old, male and female.

• Subjects 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.

• Subjects 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 within 14 days): a. Absolute neutrophil value (ANC) ≥ 1.5\*10\^9/L; b. Haemoglobin (HGB) ≥ 90g/L; c. Platelet count (PLT) ≥ 75\*10\^9/L. (2) Biochemical tests need to meet the following criteria: a. Serum albumin (ALB) ≥ 35g/L; b. Serum total bilirubin (TBIL) \< 1.5\*Upper Limit of Normal (ULN); c. Serum glutamic transaminase (AST), alanine aminotransferase (ALT) \< 2.5\*ULN; d. Serum creatinine ≤ 1.5\*ULN.

Locations
Other Locations
China
No.2 People's Hospital of Fuyang city
RECRUITING
Fuyang
Anhui province hospital
RECRUITING
Hefei
Contact Information
Primary
Lianxin Liu
liulx@ustc.edu.cn
+86 18096656677
Backup
Ji-Zhou Wang
wangjoe@ustc.edu.cn
+86 13836135864
Time Frame
Start Date: 2024-07-20
Estimated Completion Date: 2027-05-20
Participants
Target number of participants: 45
Treatments
Experimental: Donafenib 100mg PO bid + Envafolimab 300mg IH D1 q3w
Donafenib:100mg,PO,bid;Treatment cycle 6-12 months Envafolimab:300mg, IH,D1,q3w;Treatment cycle 6-12 months or 8-16 sessions Donafenib and Envafolimab will be administered until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 16 cycles of Envafolimab.
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov