The Efficacy and Safety of Iparomlimab/Tuvonralimab (Anti PD-1/CTLA-4) Combined With Albumin-bound Paclitaxel in Second-line Treatment of Patients With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
NCT ID: NCT07139587
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-09-30
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Iparomlimab and Tuvonralimab combined with albumin-paclitaxel
Iparomlimab and Tuvonralimab: 5.0mg/kg, D1, Q3w; Albumin-paclitaxel: 260mg/m², D1, Q3w
Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel
Iparomlimab/Tuvonralimab : 5.0mg/kg, D1, Q3W Albumin-bound paclitaxel: 260mg/m², D1, Q3W
Interventions
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Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel
Iparomlimab/Tuvonralimab : 5.0mg/kg, D1, Q3W Albumin-bound paclitaxel: 260mg/m², D1, Q3W
Eligibility Criteria
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Inclusion Criteria
* ECOG PS 0-2;
* Histologically confirmed advanced of the gastric cancer/gastroesophageal junction adenocarcinoma;
* Failure of first-line treatment: Progression or intolerance after receiving platinum-based (oxaliplatin/cisplatin) + fluorouracil (5-FU/ capecitabine /S-1) regimens;
* The first-line use of PD-1 inhibitors is permitted;
* At least one measurable lesion (RECIST v1.1);
* Good organ function (ANC≥1.5×109/L, PLT≥100×109/L, with normal liver and kidney functions).
Exclusion Criteria
* Active autoimmune disease;
* Previously received PD-1/CTLA-4 bispecific antibody or taxanes at first-line treatment.
18 Years
75 Years
ALL
No
Sponsors
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Qingxia Li
OTHER
Responsible Party
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Qingxia Li
Professor
Locations
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Hebei General Hospital
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-399
Identifier Type: -
Identifier Source: org_study_id
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