The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Esophageal Cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Drug: SHR-A2102 Administration by intravenous infusion for a cycle of 3 weeks. Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks. Drug: Cisplatin Administration by intravenous infusion for a cycle of 3 weeks.
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGRP2D
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages;
Time frame: through phase IB completion, an average of 1 years
Incidence and severity of AE(DLT):
According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose;
Time frame: from Day1 to 90 days after last dose
ORR:
efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1
Time frame: 18 months after the last subject was enrolled in the group
DCR
Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;
Time frame: 18 months after the last subject was enrolled in the group
DOR
Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;
Time frame: 18 months after the last subject was enrolled in the group
PFS(Investigator evaluation)
Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;
Time frame: 18 months after the last subject was enrolled in the group
OS(Investigator evaluation)
Since C1D1 and death from any cause;
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Time frame: 18 months after the last subject was enrolled in the group