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NCT Number: NCT07139587

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebei General Hospital

Shijiazhuang, Hebei, 050000, China

Location contact

Jia Chen

CONTACT

[email protected]

（+86）0311-85988973

Qingxia Li, Professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Progression-free survival（PFS）

    Time frame: 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 outcomes

  1. Overall survival（OS）

    Time frame: 4 years

    Defined as the time between the date of enrollment and the date of death (by any cause).

  2. Objective response rate（ORR）

    Time frame: 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）

  3. Disease control rate（DCR）

    Time frame: 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）

  4. Duration of Responce （DoR）

    Time frame: 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）

  5. Adverse events

    Time frame: 4 years

    Incidence of AEs, SAEs, deaths and laboratory abnormalities in all treated participants

Study contacts

Contact information is provided by the study sponsor or research team.

Qingxia Li, Professor

CONTACT

[email protected]

+8613613110158

Sponsors and collaborators

Lead sponsor

Qingxia Li

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 24, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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