About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements;
The age of signing the informed consent is 18 -70 years, regardless of gender;
Provide archived or fresh tumor tissue for vendor test;
At least one measurable lesion according to RECIST v1.1 criteria;
Disqualifiers
Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases;
Patients with uncontrolled tumor-related pain as determined by the investigator.
Moderate or severe ascites with clinical symptoms (i.e., those who required therapeutic puncture or drainage within 2 weeks before the study treatment, and only those who showed a small amount of ascites without clinical symptoms could be included in the study); Unable to control or moderate or higher amounts of pleural effusion or pericardial effusion
A history of gastrointestinal perforation and/or fistula within 6 months prior to initial medication, or significant tumor invasion of adjacent organs (large arteries or trachea, etc.), resulting in a higher risk of bleeding or fistula
Trial design
Single group
Treatments tested in this trial
SHR-A2102;Adebrelimab;Cisplatin
DrugDrug: 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.
Treatment groups
Trial outcomes
Primary outcomes
RP2D
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages;
Incidence and severity of AE(DLT):
According to NCI-CTCAE v5.0 evaluation criteria from Day 1 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
Secondary outcomes
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;
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;
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;
OS(Investigator evaluation)
Since C1D1 and death from any cause;
Sponsors and contacts
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