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

NCT07139587 | Not Yet Recruiting

• 1 other identifier: 2025-399
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Keywords

Immunotherapy; gastric cancer; gastroesophageal junction adenocarcinoma; PD-1/CTLA-4

Outcome Measures

Primary Outcomes (1)

• Progression-free survival（PFS）

  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

  3 years

Secondary Outcomes (5)

• Overall survival（OS）

  4 years

• Objective response rate（ORR）

  3 years

• Disease control rate（DCR）

  3 years

• Duration of Responce （DoR）

  4 years

• Adverse events

  4 years

Study Arms (1)

Iparomlimab and Tuvonralimab combined with albumin-paclitaxel

EXPERIMENTAL

Iparomlimab and Tuvonralimab: 5.0mg/kg, D1, Q3w; Albumin-paclitaxel: 260mg/m², D1, Q3w

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

Interventions

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

Iparomlimab/Tuvonralimab : 5.0mg/kg, D1, Q3W Albumin-bound paclitaxel: 260mg/m², D1, Q3W

Iparomlimab and Tuvonralimab combined with albumin-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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）.

You may not qualify if:

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

Sponsors & Collaborators

• Qingxia Li: lead

Study Sites (1)

Hebei General Hospital

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Qingxia Li, Professor

CONTACT

+8613613110158; lqx73@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (1)