This is a single arm，phase 2 study evaluating the safety and efficacy of Ivonescimab(AK112) combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma (ESCC). In this study, patients with advanced esophageal squamous cell carcinoma who had not received any systematic treatment in the past will be enrolled.
The research will be conducted in two stages. In the first part, 6 patients were enrolled in the group. After the last subject in the group completed at least 21 days of observation after the first medication, the researchers will conduct a preliminary safety and effectiveness assessment. If the safety and tolerability are good, it will enter the second expansion part till the study enrolled 30 patients. Patients who met the inclusion criteria were treated with AK112 (20mg/kg, intravenous infusion, d1, Q3W) in combination with albumin paclitaxel (220mg/m2, intravenous infusion, d1, Q3W) and cisplatin (75mg/m2, intravenous infusion, d1, Q3W), of which the maximum treatment time of chemotherapy was up to six cycles, and the maximum treatment time of AK112 was 24 months. Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Signed the informed consent；
Male or female patients ≥18 and ≤ 75 years old;
ECOG physical status score is 0 or 1;
Patients with non resectable or metastatic advanced ESCC confirmed by pathological ocytological examination;
Local advanced esophageal squamous cell carcinoma that can be curative through surgery or potentially cured through radiation therapy;
Suffering from other malignant tumors within the 5 years prior to enrollment. Patients with other malignant tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ, are not excluded;
Active bleeding signs of the lesion are displayed under endoscopy;
Currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration;
Single group
Ivonescimab combined with albumin paclitaxel and cisplatin
DrugIvonescimab (20mg/kg, intravenous infusion, d1, Q3W) combined with albumin paclitaxel (220mg/m2, intravenous infusion, d1, Q3W) and cisplatin (75mg/m2, intravenous infusion, d1, Q3W), of which the maximum treatment time of chemotherapy was up to six cycles, and the maximum treatment time of AK112 was 24 months.
Objective Response Rate,ORR
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Overall survival,OS
Defined as the time between signing the informed consent form to death due to various causes.
Progression free Survival,PFS
Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
Disease Control Rate,DCR
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
Duration of Response,DoR
Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause.
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading.
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