HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence: a Prospective, Multicenter, Randomized Phase II Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will evaluate the efficacy and safety of therapy perioperative treatment with HAIC combined with donafenib and sintilimab (group A)/ donafenib combined with sintilimab (group B) compared with direct surgery (group C) in resectable HCC patients who are at high risk for disease recurrence.

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

• Voluntary enrollment with written informed consent obtained

• Age 18 to 75 years (inclusive), regardless of gender

• Histologically or pathologically confirmed previously untreated hepatocellular carcinoma (HCC) or clinically diagnosed previously untreated HCC according to the AASLD guidelines.

• Initial resectable status as assessed by the investigator (expected to achieve R0 resection, sufficient liver remnant volume, and Child-Pugh class A, as per the Chinese Expert Consensus on Neoadjuvant Therapy for Liver Cancer (2023 Edition)).

• At least one measurable lesion according to mRECIST criteria.

• Tumor burden meets one of the following conditions:

‣ A single tumor with a diameter \> 5 cm;

⁃ Multiple tumors with the largest tumor diameter \> 3 cm, with \< 5 tumors in total;

⁃ Presence of portal vein tumor thrombus (Vp1-Vp2).

• Liver function: Child-Pugh score of 5-6.

• ECOG 0-1

• Life expectancy of at least 3 months.

• Women of childbearing potential (defined as not postmenopausal or surgically sterilized) must have a negative serum pregnancy test within 7 days prior to the study drug administration.

• Both women and men of childbearing potential must use reliable contraception during the study and for 60 days following the last dose of the study drug.

• For HBV-infected patients: If HBV-DNA is ≥ 10⁴ copies/ml within 14 days prior to enrollment, antiviral therapy (preferably entecavir) must be initiated to reduce HBV-DNA to \< 10⁴ copies/ml before entering the study. Antiviral therapy should continue, with regular monitoring of liver function and HBV-DNA levels.

• Adequate organ function.

Locations
Other Locations
China
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
TianJin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
Contact Information
Primary
Lu Wang, M.D.
w.lr@hotmail.com
86-18121299357
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 165
Treatments
Experimental: Group A
HAIC combined with sintilimab and donafenib
Experimental: Group B
Sintilimab and Donafenib
Active_comparator: Group C
Direct surgery
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov