This is an open-label, prospective, interventional study designed to enroll 34 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma, aiming to evaluate and observe the efficacy and safety of QL1706 in combination with DOS for the treatment of locally advanced gastric or gastroesophageal junction adenocarcinoma. Enrolled patients will receive iparomlimab and tuvonralimab in combination with the DOS regimen (docetaxel + oxaliplatin + S-1) administered in 21-day treatment cycles. Subjects who complete 3-4 cycles of treatment and are deemed suitable for surgery will undergo gastrectomy, with the specific interval between neoadjuvant therapy and surgery determined by the investigator based on actual clinical circumstances. Following surgery, clinicians will administer postoperative treatment according to the postoperative pathological assessment results and the clinical practice treatment principles of the study center. The primary endpoint is the pathological complete response rate assessed by postoperative pathological evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
5 mg/kg, intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
40 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
100 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
40 mg/m², oral, twice daily (BID), D1-14, every 21 days per cycle, for 3-4 cycles.
Subjects who complete 3-4 cycles of neoadjuvant therapy and are deemed suitable for surgery will undergo gastrectomy. The specific interval between neoadjuvant therapy and surgery will be determined by the investigator based on actual clinical circumstances.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Pathological Complete Response Rate (pCR Rate)
Defined as the proportion of patients with no residual tumor cells in the resected tumor tissue and regional lymph nodes upon pathological evaluation.
Time frame: Perioperative, upon postoperative pathological evaluation
R0 Resection Rate
The proportion of patients with microscopically margin-negative resection, with no residual tumor cells either macroscopically or microscopically, and complete resection of the lesion.
Time frame: Perioperative, upon postoperative pathological evaluation
Major Pathological Response Rate (MPR Rate)
Defined as the proportion of patients with ≤10% residual viable tumor cells in the postoperative pathological specimen.
Time frame: Perioperative, upon postoperative pathological evaluation
Objective Response Rate (ORR)
The proportion of patients achieving complete response (CR) or partial response (PR) as assessed by RECIST version 1.1 criteria.
Time frame: On Day 1 of every 2 cycles (each cycle is 21 days), prior to surgery
Disease Control Rate (DCR)
The proportion of patients achieving CR, PR, or stable disease (SD) among evaluable patients as assessed by RECIST version 1.1 criteria.
Time frame: On Day 1 of every 2 cycles (each cycle is 21 days), prior to surgery
Number of Participants with Adverse Events (AEs) and Severity Graded
Defined as all adverse events occurring from enrollment (i.e., signing of the informed consent form) through 30 days after the last dose. AEs will be coded using the MedDRA dictionary, with System Organ Class (SOC) and Preferred Term assigned to each adverse event. The severity of adverse events will be graded according to NCI CTCAE version 5.0.
Time frame: From signing of ICF through 30 days after the last dose
3-Year Disease-Free Survival Rate (DFS Rate)
Defined as the proportion of patients without recurrence or metastasis within 3 years after treatment.
Time frame: 3 years after treatment
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