The Purpose of This Study is to Evaluate the Efficacy and Safety of Gemox combined with Anlotinib and Sintilimab as first-lineTherapy for Patients With advanced combined hepatocellular-cholangiocarcinoma.
Combined hepatocellular-cholangiocarcinoma (cHCC-CCA) accounts for 0.4%-14.2% of primary hepatocellular carcinoma. As imaging and pathological diagnostic techniques for liver tumors have improved, the detection rate of cHCC-CCA puncture biopsies and surgical procedures has increased. Oxaliplatin-containing chemotherapy was previously recommended for the treatment of advanced cHCC-ICC, but its efficacy was not satisfactory. Targeted therapy and immunotherapy have made breakthroughs in both advanced HCC and CCA, providing a new direction for exploration in the treatment of advanced cHCC-CCA. Currently, targeted combination immunotherapy has become the preferred first-line treatment strategy for advanced HCC. Chemotherapy combined with immunotherapy is also the preferred first-line treatment option for advanced CCA. To balance the treatment of HCC and ICC, this study further investigates the efficacy and safety of Gemox chemotherapy combined with anlotinib and Sintilimab(anti-PD-1 monoclonal antibody) immunotherapy in advanced cHCC-ICC, to provide a new treatment strategy and reference for the clinical treatment of advanced cHCC-CCA patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Gemox chemotherapy(gemcitabine 1g/m2 ivgtt d1,d8 +oxaliplatin 85g/m2 ivgtt d1,q3w,anlotinib (8mg po d1-14 q3w )and Sintilimab (200mg ivgtt d1 q3w)
ORR
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Time frame: Every 2 cycles (each cycle is 21 days)starting from the first cycle, and every 3 cycles after 6 cycles
Safety and tolerability
Incidence of Treatment-Emergent Adverse Events,Version 5.0 and AEs leading to dose interruption or discontinuation.
Time frame: 3 months after the last administration of drugs
PFS
Progression-free survival is determined from the date of treatment to PD or death from any cause
Time frame: Every 2 cycles(each cycle is 21 days) starting from the first cycle, and every 3 cycles after 6 cycles
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Time frame: Every 2 cycles(each cycle is 21 days) starting from the first cycle, and every 3 cycles after 6 cycles
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