MedTrace Logo

A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06829797 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-29

No results posted yet for this study

Summary

To explore the efficacy of Iparomlimab and Tuvonralimab (QL1706) in combination with SOX chemotherapy versus chemotherapy alone for the neoadjuvant treatment of locally-progressed gastric/gastroesophageal union adenocarcinomas by evaluating the complete pathologic remission rate (pCR).

Conditions

  • Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Neoadjuvant Therapy(QL1706+SOX Chemotherapy)

Preoperative QL1706 combined with SOX regimen (4 cycles) → Radical surgery (D2) → Postoperative QL1706 combined with SOX regimen (4 cycles). QL1706 (50mg/2mL) , at a dose of 5mg/kg, the desired volume of drug is withdrawn and slowly infused into an IV bag of 0.9% NaCl, prepared as a diluent with a final concentration of 1-10mg/mL, mixed, and infused intravenously, Q3W, administered on the first day of each cycle.

DRUG

Neoadjuvant Therapy(SOX Chemotherapy)

Preoperative SOX regimen (4 cycles) → radical surgery (D2) → postoperative SOX regimen (4 cycles).

PROCEDURE

Radical surgery (D2)

Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy.

DRUG

Drug: Adjuvant therapy(QL1706+SOX chemotherapy)

Postoperative adjuvant therapy is 4 cycles of QL1706+SOX chemotherapy.

DRUG

Drug: Adjuvant therapy(SOX chemotherapy)

Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy.

Sponsors & Collaborators

  • Shandong Provincial Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06829797 on ClinicalTrials.gov