Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Qingxia Li
Conditions:
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Aged 18-75;
- 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
- Her2-positive gastric cancer/gastroesophageal junction adenocarcinoma;
- Active autoimmune disease;
- Previously received PD-1/CTLA-4 bispecific antibody or taxanes at first-line treatment.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07139587
Start Date
September 1 2025
End Date
December 1 2028
Last Update
September 10 2025
Active Locations (1)
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1
Hebei General Hospital
Shijiazhuang, Hebei, China, 050000