OncoMatch/Clinical Trials/NCT06766305
QL1706 Combined With SOX Used in Theperioperative Treatment
Is NCT06766305 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies QL1706 combined with SOX for gastric cancers.
Treatment: QL1706 combined with SOX — This is a single-center, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study consists of the following two phases: Phase 1: The safety introduction phase of QL1706 combined with SOX, using a 3+3 design, enrolled about 6 to 12 patients with locally advanced gastric/gastroesophageal junction adenocarcinoma (primary clinical stage ≥T3 or N+, M0) and underwent 3-week DLT evaluation. Phase 2: This phase plans to enroll 42 to 45 patients, using investigator-evaluated pCR as the primary endpoint. QL1706 is administered by intravenous infusion of RP2D as defined in Part 1 starting from cycle 1. Preoperative QL1706 RP2D combined with SOX (3 cycles) → radical surgery (D2) → postoperative QL1706 RP2D combined with SOX (5 cycles) → postoperative maintenance of QL1706 RP2D (up to 1 year before and after surgery); neoadjuvant therapy Surgery should be performed within 3 to 6 weeks after the last dosing, with a minimum interval of 4 weeks after surgery and a maximum interval of 6 weeks recommended for postoperative adjuvant therapy.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage ≥T3 (AJCC 8th edition)
primary clinical stage ≥T3 or N+, M0, according to AJCC 8th edition staging
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Have not received any anti-tumor treatment for gastric or gastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, surgery, etc.
Cannot have received: chemotherapy
Have not received any anti-tumor treatment for gastric or gastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, surgery, etc.
Cannot have received: surgery
Have not received any anti-tumor treatment for gastric or gastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, surgery, etc.
Cannot have received: immune checkpoint inhibitor
any radiation therapy, chemotherapy, or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) and other anti-tumor drugs
Lab requirements
Blood counts
neutrophil count ≥ 1.5×10^9/L; Platelet count ≥ 80×10^9/L; Hemoglobin ≥ 80 g/L
Kidney function
Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cocheroft-Gault formula)
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT ≤ 2.5 x ULN; AST ≤ 2.5 x ULN
Cardiac function
QTc > 450ms (male); QTc > 470ms (female) excluded; NYHA grade II or above heart failure, unstable angina, MI within 1 year, significant arrhythmias excluded
Normal functioning of major organs, including: Blood routine examination... Blood biochemical examination... Coagulation function... QTc > 450ms (male); QTc > 470ms (female) excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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