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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

February 29, 2028

Study Completion Date

February 29, 2028

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 QL1706 (50mg/2mL) , at a dose of 5mg/kg, the desired volume of drug is withdrawn and slowly infused into an IV bag of 0.9% NaCl, prepared as a diluent with a final concentration of 1-10mg/mL, mixed, and infused intravenously, Q3W,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

All Listed Sponsors
lead

Shandong Provincial Hospital

OTHER_GOV