Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model

PHASE2RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
HCC
Interventions
PROCEDURE

Hepatic arterial infusion chemotherapy

Patients in the neoadjuvant group received two cycles of neoadjuvant hepatic arterial infusion chemotherapy (HAIC, adoption of the FOFOLX6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days)

DRUG

Lenvatinib

Patients in the neoadjuvant therapy group received Lenvatinib before surgery(Len was started before HAIC treatment, discontinued during HAIC treatment, and discontinued approximately two weeks before surgery, Oral 8 mg or 12mg once a day depending body weight).

DRUG

Tislelizumab

Patients in the neoadjuvant therapy group received two cycles of Tislelizumab therapy before surgery (First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later)

PROCEDURE

Liver resection

Patients in the neoadjuvant therapy group were evaluated for tumor status and surgical safety after neoadjuvant therapy, and eligible patients subsequently underwent surgical resection. Patients in the direct surgery group underwent liver resection.

DRUG

Tislelizumab

Given the high risk of postoperative recurrence, patients in both groups received adjuvant Tis therapy (every 21 days for 8 cycles) starting about one month after surgery.

Trial Locations (2)

430000

RECRUITING

Huapeng Sun, Xiangyang

Unknown

RECRUITING

Enyu Liu, Jinan

All Listed Sponsors
lead

Chen Xiaoping

OTHER