This study is a single prospective, parallel, double-cohort, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of ivonescimab (AK112) combined with IP chemotherapy ± TACE in the first-line treatment of metastatic digestive system neuroendocrine cancer.
Age: 18 - 75 years old;
Metastatic digestive system neuroendocrine carcinoma (NEC) confirmed by tissue or cytological examination;
For cohort 2 only: Liver metastasis, suitable for TACE;
No previous systemic treatment; For patients who received adjuvant therapy, disease recurrence and metastasis more than 6 months after the last treatment can be regarded as first-line treatment;
Within the past 5 years, have been diagnosed with other malignant tumors (excluding carcinoma in situ, basal cell carcinoma, etc.);
Known to be allergic to any component of any study drug; have a history of severe hypersensitivity reaction to other monoclonal antibodies;
Within 4 weeks before enrollment, have received approved or investigational systemic anti-tumor treatment, including: photodynamic therapy, chemotherapy, radical radiotherapy, ablation, local radiotherapy (allowing for palliative radiotherapy for bone metastases at least 2 weeks before the study drug treatment), biological immunotherapy, targeted therapy, etc.;
Within 4 weeks before enrollment, have participated in other domestic clinical trials of drugs that have not been approved or are not yet on the market and have received corresponding trial drug treatment;
Parallel
AK112
DrugCombination treatment period (4-6 cycles): AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks Maintenance treatment period: AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks
Irinotecan
DrugCombination treatment period (4-6 cycles): Irinotecan: 65 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks
Cisplatin
DrugCombination treatment period (4-6 cycles): Cisplatin: 30 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks
TACE
Procedure/SurgeryCombination treatment period: TACE with epirubicin, 30-40 mg, every 3 weeks or every 6 weeks. The total treatment cycle is determined as needed.
progression-free survival (PFS)
PFS is defined as the time from date of treatment start to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1
objective response rate (ORR)
Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1
disease control rate (DCR)
Proportion of subjects with CR,PR, or SD based on RECIST Version 1.1.
duration of response (DOR)
Time from the first documentation of objective response to the first documented disease progression as assessed by RECIST version 1.1 or death due to any cause, whichever occurs first
overall survival (OS)
Time from the date of treatment start to death due to any cause
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