Locally Advanced Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT07828873
A Single-Arm Study of QL1706 Combined With DOS as Neoadjuvant Therapy for Locally Advanced Gastric/GEJ Adenocarcinoma
A Phase 2 study testing Iparomlimab and Tuvonralimab Injection (QL1706), Docetaxel and Oxaliplatin in people with Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Iparomlimab and Tuvonralimab Injection (QL1706), Docetaxel and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Patients with a history of interstitial lung disease (except for radiation pneumonitis not treated with corticosteroids), non-infectious pneumonitis, or active pulmonary tuberculosis; or a history of active pulmonary tuberculosis within 1 year prior to enrollment, or more than 1 year prior to enrollment if not adequately treated.
- Pregnant or breastfeeding women.
- Other concomitant diseases that, in the opinion of the Investigator, pose a serious risk to the subject's safety or may interfere with the subject's ability to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yongxu Jia, 66271157, jiayongxu111@126.com
About this study
Official title: A Single-Arm, Prospective, Open-Label Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
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.
- Being tested
- Iparomlimab and Tuvonralimab Injection (QL1706), Docetaxel, Oxaliplatin, Tegafur-Gimeracil-Oteracil, Gastrectomy
- Keywords
- Iparomlimab/Tovonralimab Combination Antibody, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, DOS Regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab Injection (QL1706)Drug
Also called QL1706
5 mg/kg, intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
DocetaxelDrug
40 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
OxaliplatinDrug
100 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
Tegafur-Gimeracil-OteracilDrug
40 mg/m², oral, twice daily (BID), D1-14, every 21 days per cycle, for 3-4 cycles.
GastrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Iparomlimab and Tuvonralimab Injection (QL1706); Drug: Docetaxel; Drug: Oxaliplatin; Drug: Tegafur-Gimeracil-Oteracil; Procedure: Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative, upon postoperative pathological evaluation
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yongxu Jia, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828873
- Sponsor's protocol ID
- HN-QL1706-G/GEJ-002
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No