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

Not Applicable

Not yet recruiting

• Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel

• Registration Number: NCT07139587
• Lead Sponsor: Qingxia Li

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-17
• Study First Submitted QC: 2025-08-17
• Study First Posted: 2025-08-24
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-10
• Primary Completion: 2027-08
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• Her2-positive gastric cancer/gastroesophageal junction adenocarcinoma;
• Active autoimmune disease;
• Previously received PD-1/CTLA-4 bispecific antibody or taxanes at first-line treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iparomlimab and Tuvonralimab combined with albumin-paclitaxel	Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel	Iparomlimab and Tuvonralimab: 5.0mg/kg, D1, Q3w; Albumin-paclitaxel: 260mg/m², D1, Q3w

Primary Outcome Measures

Name	Time	Method
Progression-free survival（PFS）	3 years	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

Secondary Outcome Measures

Name	Time	Method
Overall survival（OS）	4 years	Defined as the time between the date of enrollment and the date of death (by any cause).
Objective response rate（ORR）	3 years	Defined as the percentage of participants whose BOR is either a confirmed CR or PR（assessed by INV based on RECIST 1.1）
Disease control rate（DCR）	3 years	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）
Duration of Responce （DoR）	4 years	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）
Adverse events	4 years	Incidence of AEs, SAEs, deaths and laboratory abnormalities in all treated participants

Trial Locations

Locations (1)

Hebei General Hospital; 🇨🇳 Shijiazhuang, Hebei, China