Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYongxu Jia

About this trial

This is a single-center, prospective, exploratory clinical study. Eligible patients will be enrolled and receive iapalolimab combined with DOS regimen (docetaxel + oxaliplatin + tegafur-gimeracil-oteracil potassium). The study aims to further explore the efficacy and safety of iapalolimab plus DOS regimen for locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 34 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma will be enrolled. Each treatment cycle lasts 21 days. After 3-4 cycles, patients who are assessed as operable by investigators will undergo surgical resection, and postoperative pathological results will be evaluated. The primary outcome measure is the pathological complete response rate. Investigators will determine subsequent treatment regimens based on patients' pathological findings and routine clinical practice at the study center. Radiological assessment of tumor response is recommended every 2 cycles.

Eligibility criteria

Qualifiers

Aged 18-75 years old, male or female;

Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction;

Clinical stage cT3-4a/N+M0;

ECOG performance status 0-1;

Disqualifiers

Aged 18-75 years old, male or female;

Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction;

Clinical stage cT3-4a/N+M0;

ECOG performance status 0-1;

Trial design

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab Injection (QL1706)
  • S-1
  • Oxaliplatin
  • Docetaxel

Treatment groups

34 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yongxu Jia

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Sponsor institution