This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
5 mg/kg, ivdrip, Day 1, Q3W, until progressive disease or intolerable toxicity.
130 mg/m2, ivdrip, Day 1, Q3W, for the first 6 cycles.
1000 mg/m2, po, bid, Days 1-14, Q3W, until progressive disease or intolerable toxicity.
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGprogression-free survival (PFS)
The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1).
Time frame: 12 months after the last subject participating in
overall survival (OS)
The time from the starting date of study drug to the date of death due to any cause.
Time frame: 12 months after the last subject participating in
objective response rate (ORR)
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.
Time frame: 6 months after the last subject participating in
duration of response (DOR)
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Time frame: 12 months after the last subject participating in
disease control rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
Time frame: 12 months after the last subject participating in
Safety (adverse event)
The rates of adverse events.
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.