A Phase II, Single-Arm, Prospective Trial on the Efficacy and Safety of QL1706 Combination Regimen as Second-Line Therapy for Targeted-Immunotherapy-Resistant Hepatocellular Carcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2028

Conditions
Hepatocellular Carcinoma (HCC)Second Line Treatment
Interventions
PROCEDURE

HAI-FOLFOX + bevacizumab + QL1706

"Arm 1:~HAI-FOLFOX Administration (Day 1 of Each Cycle) Super-selective insertion the arterial catheter into the tumor-feeding artery, then infusion: Oxaliplatin: 85 mg/m², Leucovorin: 400 mg/m², 5-FU: 2500 mg/m²~Administer bevacizumab (7.5 mg/kg; total dose capped at 300 mg or 400 mg) via arterial infusion.~Then QL1706 (5 mg/kg, IV infusion, Q3W).~Treatment Schedule: Repeat HAI-FOLFOX + arterial bevacizumab every 3 weeks (max 6 cycles), followed by QL1706 maintenance (Q3W)."

PROCEDURE

TACE + bevacizumab + TAS-102 + QL1706

"Arm 2:~On-Demand TACE (Lipiodol: ≤10 mL, mixed with platinum + doxorubicin agent, each ≤50 mg) to form an emulsion. Repeat TACE until TACE resistance develops (typically \~4 sessions).~Administer bevacizumab (7.5 mg/kg; total dose capped at 300 mg or 400 mg) via intra-arterial route.~After first TACE, begin TAS-102 (15 mg/m² po BID) once liver function recovers to acceptable levels.~Then QL1706 (5 mg/kg, IV infusion, Q3W)."

Trial Locations (1)

510060

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

lead

Sun Yat-sen University

OTHER