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Gastroesophageal Junction AdenocarcinomaPhase 2NCT07776639

Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction

A Phase 2 study testing Iparomlimab and Tuvonralimab Injection (QL1706), S-1 and Oxaliplatin in people with Gastroesophageal Junction Adenocarcinoma and Gastric Adenocarcinoma, run by Yongxu Jia at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-center, prospective, exploratory clinical study. Eligible patients will be enrolled and receive iapalolimab combined with DOS regimen (docetaxel + oxaliplatin + tegafur-gimeracil-oteracil potassium). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Iparomlimab and Tuvonralimab Injection (QL1706), S-1 and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
10 May 2026to Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18-75 years old, male or female;
  • Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction;
  • Clinical stage cT3-4a/N+M0;
  • ECOG performance status 0-1;
  • Adequate function of major organs assessed within 7 days before treatment:
  • Hematological indicators (without blood transfusion within 14 days):
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  • Hemoglobin (HB) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet (PLT) ≥80×10⁹/L;
  • Biochemical indicators:
  • 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;
  • Assessed by Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
  • Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN;
  • Subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the end of study treatment;
  • Subjects voluntarily participate in this study and sign written informed consent.
  • Aged 18-75 years old, male or female;
  • Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction;
  • Clinical stage cT3-4a/N+M0;
  • ECOG performance status 0-1;
  • Adequate function of major organs assessed within 7 days before treatment:
  • Hematological indicators (without blood transfusion within 14 days):
  • Hemoglobin (HB) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet (PLT) ≥80×10⁹/L;
  • Biochemical indicators:
  • 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;
  • Assessed by Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
  • Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN;
  • Subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the end of study treatment;
  • Subjects voluntarily participate in this study and sign written informed consent.

Who cannot join

  • History of hypersensitivity to any component of QL1706, tegafur-gimeracil-oteracil potassium, oxaliplatin, docetaxel, or any of their excipients;
  • History of other malignant tumors within the past 5 years or concurrent other malignant tumors, except cured carcinoma in situ of cervix, non-melanoma skin cancer, and superficial bladder tumors;
  • Patients with distant metastasis or unresectable disease;
  • Prior receipt of immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.);
  • Received any anti-tumor agents within 4 weeks prior to the first study drug administration;
  • Patients with intestinal obstruction (including incomplete intestinal obstruction) or other gastrointestinal diseases that may lead to gastrointestinal hemorrhage, perforation or obstruction;
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  • Patients with any bleeding event ≥ CTCAE Grade 3, unhealed wounds, ulcers or fractures within 4 weeks before screening;
  • Concurrent enrollment in another interventional clinical trial, except observational (non-interventional) clinical trials or follow-up phase of interventional trials;
  • Subjects requiring systemic treatment with corticosteroids (>10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks before the first study drug administration;
  • Received live vaccines within 4 weeks prior to the first study drug administration;
  • Underwent major surgery or suffered trauma within 4 weeks before the first study drug administration;
  • Active autoimmune disease or history of autoimmune disease, except vitiligo or childhood asthma/allergy that has resolved and requires no intervention in adulthood;
  • History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
  • Subjects with inadequately controlled cardiovascular clinical symptoms or diseases;
  • Severe infection (CTCAE Grade > 2) occurring within 4 weeks prior to the first study drug administration;
  • History of interstitial lung disease (except radiation pneumonia without corticosteroid treatment), non-infectious pneumonia, active pulmonary tuberculosis infection; patients with history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with history of active pulmonary tuberculosis infection more than 1 year ago without standardized treatment;
  • Pregnant or breastfeeding women;
  • Other concomitant diseases that, in the investigator's opinion, may seriously endanger the subject's safety or prevent the subject from completing the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Single-Arm, Prospective, Open-Label Clinical Study of Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction

This is a single-center, prospective, exploratory clinical study. Eligible patients will be enrolled and receive iapalolimab combined with DOS regimen (docetaxel + oxaliplatin + tegafur-gimeracil-oteracil potassium). The study aims to further explore the efficacy and safety of iapalolimab plus DOS regimen for locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 34 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma will be enrolled. Each treatment cycle lasts 21 days. After 3-4 cycles, patients who are assessed as operable by investigators will undergo surgical resection, and postoperative pathological results will be evaluated. The primary outcome measure is the pathological complete response rate. Investigators will determine subsequent treatment regimens based on patients' pathological findings and routine clinical practice at the study center. Radiological assessment of tumor response is recommended every 2 cycles.

Being tested
Iparomlimab and Tuvonralimab Injection (QL1706), S-1, Oxaliplatin, Docetaxel

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

    5 mg/kg intravenous infusion on Day 1 every 3 weeks.

  • S-1Drug

    40 mg/m² orally twice daily on Day 1-14 every 3 weeks.

  • OxaliplatinDrug

    100 mg/m² intravenous infusion on Day 1 every 3 weeks.

  • DocetaxelDrug

    40 mg/m² intravenous infusion on Day 1 every 3 weeks.

Study groups in NCT07776639
Study groupRoleWhat they receive
QL1706 combined with DOS neoadjuvant therapyExperimentalNeoadjuvant combination therapy with QL1706 plus S-1, oxaliplatin and docetaxel (DOS) for locally advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma.
Receives: Drug: Iparomlimab and Tuvonralimab Injection (QL1706); Drug: S-1; Drug: Oxaliplatin; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR) rate

    Pathological complete response (pCR) is defined as no residual tumor cells identified in the primary tumor bed and regional lymph nodes after surgical resection, which means complete pathological regression of the tumor.

    Measured: Up to 24 weeks after completion of neoadjuvant therapy and surgical resection

Secondary outcomes (6)

  1. R0 Resection Rate

    R0 resection is defined as complete resection of the tumor lesion. No residual tumor is visible macroscopically, and no tumor cells can be identified microscopically at the resection margins without any residual tumor components, achieving radical surgical effect. The R0 resection rate refers to the proportion of patients who achieve R0 resection.

    Measured: Up to 24 weeks after completion of neoadjuvant therapy and gastrectomy.

  2. Objective Response Rate

    Objective Response Rate (ORR) is defined as the proportion of subjects achieving confirmed complete response (CR) plus partial response (PR) as assessed per RECIST version 1.1

    Measured: Up to 12 weeks after completion of neoadjuvant therapy, prior to gastrectomy.

  3. Major Pathological Response (MPR) Rate

    Major pathological response (MPR) is defined as ≤10% viable residual tumor cells both in the primary tumor bed and regional lymph nodes after gastrectomy. The MPR rate refers to the proportion of subjects achieving MPR after gastrectomy.

    Measured: Up to 24 weeks after completion of neoadjuvant therapy and gastrectomy.

  4. Disease Control Rate

    Disease Control Rate (DCR) is defined as the proportion of subjects achieving confirmed stable disease (SD), partial response (PR), and complete response (CR) as assessed per RECIST version 1.1.

    Measured: Up to 12 weeks after completion of neoadjuvant therapy, prior to gastrectomy

  5. Incidence of Adverse Events

    Safety will be evaluated by monitoring the incidence, type, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) according to CTCAE. Assessments include physical examinations, routine laboratory tests, and continuous adverse event collection.

    Measured: From the start of neoadjuvant therapy until 30 days after gastrectomy.

  6. 3-year Disease-Free Survival (DFS) Rate

    Disease-free survival (DFS) is defined as the time from the date of randomization to the first documented disease recurrence (local recurrence, regional recurrence or distant metastasis) or death from any cause, whichever occurs first. The 3-year DFS rate is the proportion of subjects who remain alive without disease recurrence at 3 years after randomization.

    Time Frame: From the date of randomization until 3 years after randomization

    Measured: From the date of gastrectomy until 3 years after gastrectomy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study start10 May 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

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
Model description
All eligible participants will receive the same investigational intervention without a control group.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07776639
Sponsor's protocol ID
HN-QL1706-G/GEJ-001
Status last verified
Sep 2026
First submitted
10 Aug 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iparomlimab and Tuvonralimab Injection (QL1706), S-1 and Oxaliplatin in people with Gastroesophageal Junction Adenocarcinoma and Gastric Adenocarcinoma, run by Yongxu Jia at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) rate (time frame: Up to 24 weeks after completion of neoadjuvant therapy and surgical resection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07776639.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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