About this trial
To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1) Age: 18 ~ 75 years old, male and female;
2) ECOG score: 0 or 1;
3) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology;
4) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline containing PD-1/PD-L1 was CR, PR or SD;
Disqualifiers
1) Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease progression more than 6 months after the last chemotherapy were excluded;
2) HER2-positive patients;
3) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment;
4) Patients with severe liver and kidney insufficiency or heart insufficiency;
Trial design
Single group
Treatments tested in this trial
Paclitaxel for injection (albumin-bound)
Drug100 mg/m2, day 1, day 8, every 21 days for a cycle.
Adebrelimab
Drug20mg/kg or 1200mg, the first day, every 21 days as a cycle.
Apatinib mesylate
Drug250mg once a day for 5 consecutive days and discontinue for 2 days
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate(ORR)
Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.
Secondary outcomes
Disease control rate(DCR)
Refers to the proportion of all subjects with the best overall response (BOR) according to RECIST1.1 criteria as complete remission (CR), partial remission (PR) and stable disease (SD).
Progression-free survival (PFS)
PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by RECIST1.1 criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.
Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR)
It refers to the time between the first evaluation of a tumor as CR or PR and the second evaluation as Progressive Disease (PD) or death from any cause.
Overall survival(OS)
Defined as the time from the date of the first dose to the death of the subject from any cause.
Other outcomes
Explore potential biomarkers in tumor tissue
ORR corresponding to PD-L1 negative expression, positive expression (TPS≥1%), low expression (\<10%), high expression (TPS\>50%)
Sponsors and contacts
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