A Phase 2 interventional study of Iparomlimab and Tuvonralimab Injection (QL1706) and Docetaxel in Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, sponsored by The First Affiliated Hospital of Zhengzhou University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Enrolled patients receive QL1706 (5 mg/kg, IV, D1) combined with the DOS regimen (docetaxel 40 mg/m², IV, D1 + oxaliplatin 100 mg/m², IV, D1 + S-1 40 mg/m², PO, BID, D1-14), administered every 21 days per cycle for 3-4 cycles. Subjects who complete neoadjuvant therapy and are deemed suitable for surgery will undergo gastrectomy, followed by subsequent treatment based on postoperative pathological assessment.
Drug: Iparomlimab and Tuvonralimab Injection (QL1706) · Drug: Docetaxel · Drug: Oxaliplatin · Drug: Tegafur-Gimeracil-Oteracil · Procedure: Gastrectomy
5 mg/kg, intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
Also known as: QL1706
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.
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
Peripheral blood ctDNA Biomarker
Serial peripheral blood samples are collected at baseline and during neoadjuvant treatment. Circulating tumor DNA (ctDNA) molecular profiles are detected by next-generation sequencing. The exploratory analysis aims to evaluate the correlation between dynamic ctDNA alterations and treatment efficacy and safety outcomes.
Time frame: Baseline and on Day 1 of every 2 cycles (each cycle is 21 days, synchronized with imaging evaluation), until prior to surgery
Peripheral blood multi-omics biomarker levels
Serial peripheral blood samples are collected at baseline and during neoadjuvant treatment. Genomic, transcriptomic, and proteomic multi-omics profiles in peripheral blood are detected using a multi-omics sequencing platform. Exploratory analyses are performed to explore the association between peripheral blood multi-omics molecular features and treatment efficacy and safety.
Time frame: Baseline and on Day 1 of every 2 cycles (each cycle is 21 days, synchronized with imaging evaluation), until prior to surgery
Tumor tissue multi-omics and tumor microenvironment immune signatures
Tumor specimens including fresh tissues and formalin-fixed paraffin-embedded (FFPE) sections are collected at baseline (pre-treatment biopsy) and immediately after radical gastrectomy. Baseline and post-operative tumor tissues are subjected to genomic, transcriptomic, and proteomic multi-omics sequencing to characterize tumor biomarkers and tumor microenvironment immune molecular features. All tissue collections do not interfere with routine clinical pathological diagnosis, and are performed with written informed consent. Exploratory analyses will investigate the associations between tissue molecular signatures and treatment efficacy and safety outcomes.
Time frame: Baseline (pre-treatment biopsy) and perioperative (immediately after radical gastrectomy)
Plan to share: No
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The First Affiliated Hospital of Zhengzhou University