A Single-Arm Study of QL1706 Combined With DOS as Neoadjuvant Therapy for Locally Advanced Gastric/GEJ Adenocarcinoma

NCT07828873 | Not Yet Recruiting Phase 2

• 1 other identifier: HN-QL1706-G/GEJ-002
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Keywords

Iparomlimab/Tovonralimab Combination Antibody; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; DOS Regimen

Outcome Measures

Primary Outcomes (1)

• 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.

  Perioperative, upon postoperative pathological evaluation

Secondary Outcomes (6)

• R0 Resection Rate

  Perioperative, upon postoperative pathological evaluation

• Major Pathological Response Rate (MPR Rate)

  Perioperative, upon postoperative pathological evaluation

• Objective Response Rate (ORR)

  On Day 1 of every 2 cycles (each cycle is 21 days), prior to surgery

• Disease Control Rate (DCR)

  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

  From signing of ICF through 30 days after the last dose

Other Outcomes (3)

• Peripheral blood ctDNA Biomarker

  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

  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

  Baseline (pre-treatment biopsy) and perioperative (immediately after radical gastrectomy)

Study Arms (1)

Iparomlimab and Tuvonralimab Injection (QL1706) Plus DOS Neoadjuvant Therapy Arm

EXPERIMENTAL

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

Interventions

Iparomlimab and Tuvonralimab Injection (QL1706) DRUG

5 mg/kg, intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.

Also known as: QL1706

Iparomlimab and Tuvonralimab Injection (QL1706) Plus DOS Neoadjuvant Therapy Arm

Docetaxel DRUG

40 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.

Iparomlimab and Tuvonralimab Injection (QL1706) Plus DOS Neoadjuvant Therapy Arm

Oxaliplatin DRUG

100 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.

Iparomlimab and Tuvonralimab Injection (QL1706) Plus DOS Neoadjuvant Therapy Arm

Tegafur-Gimeracil-Oteracil DRUG

40 mg/m², oral, twice daily (BID), D1-14, every 21 days per cycle, for 3-4 cycles.

Iparomlimab and Tuvonralimab Injection (QL1706) Plus DOS Neoadjuvant Therapy Arm

Gastrectomy PROCEDURE

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.

Iparomlimab and Tuvonralimab Injection (QL1706) Plus DOS Neoadjuvant Therapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years; male or female.
• Previously untreated, resectable adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
• Clinical stage cT3-4a/N+ M0.
• ECOG performance status 0-1.
• Adequate organ function within 7 days prior to treatment, meeting the following criteria: (1) Complete blood count (CBC) criteria (without blood transfusion within 14 days): Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L; (2) Serum chemistry criteria: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60 mL/min; (3) Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%). (4) Thyroid function: thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN).
• Participants of childbearing potential must agree to use effective contraception during the study period and for 6 months after study completion.
• The participant voluntarily agrees to participate in this study and signs the informed consent form.

You may not qualify if:

• Known history of hypersensitivity or allergy to QL1706 or its excipients, tegafur/gimeracil/oteracil (S-1), oxaliplatin, docetaxel, or any of their excipients.
• History of another malignancy within 5 years prior to screening or concurrent malignancy, except for curatively treated carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors.
• Patients with distant metastasis and/or unresectable disease;
• Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, and anti-CTLA-4 agents.
• Receipt of any antineoplastic agents within 4 weeks prior to the first dose of study drug.
• Patients with gastrointestinal disorders such as intestinal obstruction (including partial obstruction), or those with evidence or risk of gastrointestinal bleeding, perforation, or obstruction.
• Any bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment, or unhealed wounds, ulcers, or fractures.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.
• Subjects requiring systemic therapy with corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of study drug.
• Receipt of live or live-attenuated vaccine within 4 weeks prior to the first dose of study drug.
• Major surgery or significant trauma within 4 weeks prior to the first dose of study drug.
• Active or history of autoimmune disease, with the exception of vitiligo or resolved childhood asthma/atopy that requires no intervention in adulthood.
• History of immunodeficiency, including HIV infection, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation.
• Subjects with inadequately controlled cardiovascular clinical symptoms or diseases.
• Severe infection (CTCAE Grade \> 2) within 4 weeks prior to the first dose of study drug.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead
• Qilu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Interventions

Docetaxel; Oxaliplatin; tegafur-gimeracil-oteracil; Gastrectomy

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Yongxu Jia

CONTACT

66271157; jiayongxu111@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)