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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingxia Li

OTHER

Sponsor Role lead

Responsible Party

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Qingxia Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hebei General Hospital

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Central Contacts

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Qingxia Li, Professor

Role: CONTACT

+8613613110158

Facility Contacts

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Jia Chen

Role: primary

(+86)0311-85988973

Other Identifiers

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2025-399

Identifier Type: -

Identifier Source: org_study_id

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