QL1706-SOX vs SOX Alone as Neoadjuvant Therapy for Resectable Diffuse-Type Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

The goal of this randomized, open-label, phase II clinical trial is to determine whether adding the PD-1/CTLA-4 bispecific antibody QL1706 to standard SOX chemotherapy increases the pathological complete response rate in adults aged 18-75 years with resectable, locally advanced, diffuse-type, HER2-negative gastric adenocarcinoma (cT3-4aNxM0). Participants will be randomly assigned (1:1) to receive 3-4 neoadjuvant cycles of QL1706 plus SOX or SOX alone every 3 weeks, followed by curative-intent gastrectomy with D2 lymphadenectomy, and will be monitored post-operatively every 3 months for 2 years and every 6 months thereafter for recurrence, survival, and safety.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • QL1706 (Iparomlimab/Tuvonralimab)
  • SOX Chemotherapy

Treatment groups

74 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

First Affiliated Hospital of Suzhou Medical College

Collaborator

The Affiliated Hospital of Xuzhou Medical University

Collaborator

The Affiliated Jiangning Hospital of Nanjing Medical University

Collaborator