NCT06829797

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

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(STAR-03)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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 QL1706 (50mg/2mL) , at a dose of 5mg/kg, the desired volume of drug is withdrawn and slowly infused into an IV bag of 0.9% NaCl, prepared as a diluent with a final concentration of 1-10mg/mL, mixed, and infused intravenously, Q3W,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.

Timeline

• Start date: 2025-02-28
• Primary completion: 2028-02-29
• Completion: 2028-02-29
• First posted: 2025-02-17
• Last updated: 2025-02-17