Intrahepatic cholangiocarcinoma (ICC) has an increasing global incidence, and over 70% of patients are diagnosed at unresectable stages with limited survival benefits from standard first-line chemotherapy regimens. Hepatic arterial infusion chemotherapy (HAIC) delivers high-concentration local chemotherapy to liver tumors, while the PD-1/CTLA-4 dual antibody iparomlimab and tuvonralimab (QL1706) combined with bevacizumab can reshape the immunosuppressive tumor microenvironment and exert synergistic anti-tumor effects.The purpose of this study is to evaluate the efficacy and safety of HAIC-FOLFOX plus QL1706 and bevacizumab as first-line therapy for patients with unresectable HER2-negative intrahepatic cholangiocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Eligible patients were treated with HAIC plus QL1706 and bevacizumab. On the treatment day, continuous hepatic artery chemotherapy infusion was administered via an indwelling catheter connected to a micro-infusion pump. The infusion regimen included oxaliplatin 130 mg/m² over 3 hours, leucovorin 400 mg/m² over 1.5 hours, 5-FU 400 mg/m² over 2 hours, and 5-FU 2400 mg/m² over 46 hours. The catheter was removed after infusion completion. On the subsequent morning, patients received intravenous QL1706 (7.5 mg/kg) and bevacizumab (15 mg/kg), and were discharged after infusion. Treatment was repeated every 3-4 weeks for up to six cycles. Patients with favorable responses received continuous systemic maintenance therapy. Maintenance treatment was continued until death, intolerable toxicity, or loss of clinical benefit, with therapeutic regimens adjusted according to individual clinical status.
Sun Yat-sen university cancer center
Guangzhou, Guangdong, China
RECRUITINGobjective response rate,ORR
ORR was defined as the proportion of patients achieving best overall response of complete response (CR) or partial response (PR) per RECIST 1.1.
Time frame: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.
disease control rate, DCR
DCR was defined as the proportion of patients achieving a best overall response of complete response (CR), partial response (PR), or stable disease.
Time frame: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.
progression-free survival, PFS
PFS was defined as the time from randomization to first documented tumor progression per RECIST 1.1 or death from any cause, including death without prior disease progression. Patients without progression at data cutoff or lost to follow-up were censored at the date of last adequate tumor assessment.
Time frame: From date of randomization until the date of first documented progression or death, assessed up to 24 months.
Overall survival, OS
OS was defined as the time from first dose of study treatment to death from any cause. Patients who were alive at data cutoff or lost to follow-up were censored at the date last known to be alive.
Time frame: From date of first study treatment until death from any cause, assessed up to 36 months.
Safety evaluation
Treatment-related adverse events were assessed according to the CTCAE 5.0 criteria.
Time frame: From the date of first study treatment until 90 days after the last dose of study treatment.
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