The goal of this clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-paclitaxel in the second-line treatment of patients with advanced gastric/gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1. Can the combination of Iparomlimab/Tuvonralimab and albumin-paclitaxel for advanced gastric cancer/gastroesophageal junction cancer who has progressed or is intolerant to first-line SOC prolong the PFS and OS, improve ORR, DCR, and prolong DoR; 2. Whether Iparomlimab/Tuvonralimab ( anti PD-1/CTLA-4) combined with albumin-paclitaxel for second-line treatment remains effective for patients who have progressed from first-line PD-1±chemotherapy; 3. The safety and tolerability of Iparomlimab/Tuvonralimab in combination with albumin-paclitaxel for second-line treatment.Participants will:1. Use Iparomlimab/Tuvonralimab 5.0mg/kg, D1, Q3W; At least 30 minutes later, administer the chemotherapy albumin-paclitaxel: 260mg/m², D1, Q3W, and complete the infusion within 30 minutes. The combined regimen was administered every 3 weeks, with efficacy evaluated every 2 cycles (RECIST 1.1) until disease progression, intolerable toxicity or patient withdrawal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Iparomlimab/Tuvonralimab : 5.0mg/kg, D1, Q3W Albumin-bound paclitaxel: 260mg/m², D1, Q3W
Hebei General Hospital
Shijiazhuang, Hebei, China
Progression-free survival（PFS）
Assessed by INV based on RECIST 1.1, defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first
Time frame: 3 years
Overall survival（OS）
Defined as the time between the date of enrollment and the date of death (by any cause).
Time frame: 4 years
Objective response rate（ORR）
Defined as the percentage of participants whose BOR is either a confirmed CR or PR（assessed by INV based on RECIST 1.1）
Time frame: 3 years
Disease control rate（DCR）
Defined as the percentage of participants who have a BOR of CR, PR, SD, or NON-CR/NON-PD（assessed by INV based on RECIST 1.1）
Time frame: 3 years
Duration of Responce （DoR）
Defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first（assessed by INV based on RECIST 1.1）
Time frame: 4 years
Adverse events
Incidence of AEs, SAEs, deaths and laboratory abnormalities in all treated participants
Time frame: 4 years
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