Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT07400315

First-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Dual Immunotherapy Combined With Chemotherapy

A Phase 2 study testing Iparomlimab and Tuvonralimab Injection in combination with TFOX in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

A prospective, single-arm, multicenter, Phase II clinical study of Apatolimab Tovolimab (QL1706) in combination with modified FLOT regimen (TFOX) as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric or Gastroesophageal Junction Adenocarcinoma
What is being tested?: Iparomlimab and Tuvonralimab Injection in combination with TFOX
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: No sites listed yet
Study dates: 1 Mar 2026to 31 Mar 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

1. The participant voluntarily agrees to participate in this study, signs the informed consent form, and strictly adheres to the requirements of the study protocol.
2. Age ≥18 years and ≤75 years at enrollment, regardless of gender.
3. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma, with inclusion criteria specifying HER2- status (HER2+ status defined as IHC3+ or IHC2+ and FISH+).
4. No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma; previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 12 months prior to the diagnosis of unresectable or metastatic disease.
5. At least one measurable tumor lesion according to RECIST 1.1 criteria.
6. ECOG PS of 0 or 1.

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7. Life expectancy ≥3 months.
8. Fully recovered from any toxicities related to prior treatments prior to enrollment in the study.
9. BMI >18.
10. Adequate function of major organs
11. Fertile subjects must use appropriate contraception during the study and for 120 days after the end of the study. They must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breastfeeding.

Who cannot join

1. Any unstable systemic disease: including active infection, uncontrolled hypertension, unstable angina, angina that started within the last 3 months, congestive heart failure (New York Heart Association [NYHA] ≥Class II), myocardial infarction within 6 months prior to enrollment, severe arrhythmias requiring medication, or hepatic, renal, or metabolic diseases.
2. Symptomatic brain and/or leptomeningeal metastases.
3. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
4. QT/QTc interval >450 ms for males, >470 ms for females.
5. History of other malignancies within 5 years prior to enrollment, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
6. History of organ transplantation or autologous/allogeneic stem cell transplantation.

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7. Currently receiving systemic immunotherapy or hormone therapy other than physiologic replacement therapy.
8. Other concurrent anti-tumor treatments.
9. Known hypersensitivity or allergic reaction to any component of the study treatment.
10. Previous exposure to docetaxel or oxaliplatin (except for adjuvant chemotherapy).
11. Previous exposure to immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or any immunotherapy targeting tumor immune mechanisms.
12. Participants with severe bone marrow failure.
13. Any disease, metabolic disorder, or physical examination or laboratory findings that suggest contraindications to the study drug or high-risk factors for treatment complications.
14. Known or self-reported human immunodeficiency virus (HIV) infection.
15. Participants who are HBV or HCV positive.
16. Pregnant or breastfeeding.
17. Received a live vaccine within 4 weeks prior to the first dose, or plans to receive a live vaccine during the study.
18. Participated in any investigational drug treatment or used any investigational device within 4 weeks prior to the first dose.
19. Any condition that the investigator believes may pose a risk to the participant receiving the study drug, or may interfere with the evaluation of the study drug, the safety of the participant, or the interpretation of the study results.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yanhong Gu contact

+025-68307881

YanhongGu@njmu.edu.cn

About this study

Official title: A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Modified FLOT Regimen (TFOX) as First-line Treatment for HER2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma
Being tested: Iparomlimab and Tuvonralimab Injection in combination with TFOX
Keywords: Gastric or Gastroesophageal Junction Adenocarcinoma, Iparomlimab and Tuvonralimab Injection, TFOX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iparomlimab and Tuvonralimab Injection in combination with TFOXDrug
Participants enrolled will receive QL1706 (5 mg/kg, Q3W, d1) + docetaxel (50 mg/m², Q3W, d1) + oxaliplatin (100 mg/m², Q3W, d1) + leucovorin (LV) (400 mg/m², Q3W, d1) + 5-fluorouracil (5-FU) (2400 mg/m², Q3W, continuous infusion for 46 hours). The treatment cycle is 21 days, continuing until disease progression, intolerable toxicity, the investigator determines that the participant no longer benefits, the participant withdraws informed consent, QL1706 treatment is completed for 2 years, or other reasons specified in the protocol.Other Name:

Study groups in NCT07400315
Study group	Role	What they receive
Experimental	Experimental	Not described Receives: Drug: Iparomlimab and Tuvonralimab Injection in combination with TFOX

What is being measured

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

Median progression-free survival
Measured: 1 year

Secondary outcomes (7)

Objective response rate ,ORR
Measured: 1 year
Disease Control Rate
Measured: 1 year
Duration Of Response
Measured: 1 year
Overall survival ,OS
Measured: up to 5 years after treatment discontinuation
12-month survival rate
Measured: 12-month
24-month survival rate
Measured: 24-month
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From ICF through 100 days after the last dose of study treatment

Timeline

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

1 Mar 202631 Mar 2029

First posted10 Feb 2026
Study start1 Mar 2026 (estimated)
Primary completion31 Dec 2028 (estimated)
Study completion31 Mar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
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: 64 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07400315
Sponsor's protocol ID: QL-GasC-QIBA-3035
Status last verified: Jan 2026
First submitted: 20 Jan 2026
Last updated: 10 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Modified FLOT Regimen (TFOX) as First-line Treatment for HER2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT07400315
Acronym / sponsor ID: QL-GasC-QIBA-3035
Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma
Keywords: Gastric or Gastroesophageal Junction Adenocarcinoma, Iparomlimab and Tuvonralimab Injection, TFOX
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 64 participants (estimated)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Study start: 1 Mar 2026 (estimated)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Mar 2029 (estimated)
First posted: 10 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Drug: Iparomlimab and Tuvonralimab Injection in combination with TFOX

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

1. The participant voluntarily agrees to participate in this study, signs the informed consent form, and strictly adheres to the requirements of the study protocol.
2. Age ≥18 years and ≤75 years at enrollment, regardless of gender.
3. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma, with inclusion criteria specifying HER2- status (HER2+ status defined as IHC3+ or IHC2+ and FISH+).
4. No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma; previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 12 months prior to the diagnosis of unresectable or metastatic disease.
5. At least one measurable tumor lesion according to RECIST 1.1 criteria.

Key exclusion criteria (19 listed)

1. Any unstable systemic disease: including active infection, uncontrolled hypertension, unstable angina, angina that started within the last 3 months, congestive heart failure (New York Heart Association [NYHA] ≥Class II), myocardial infarction within 6 months prior to enrollment, severe arrhythmias requiring medication, or hepatic, renal, or metabolic diseases.
2. Symptomatic brain and/or leptomeningeal metastases.
3. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
4. QT/QTc interval >450 ms for males, >470 ms for females.
5. History of other malignancies within 5 years prior to enrollment, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Iparomlimab and Tuvonralimab Injection in combination with TFOXParticipants enrolled will receive QL1706 (5 mg/kg, Q3W, d1) + docetaxel (50 mg/m², Q3W, d1) + oxaliplatin (100 mg/m², Q3W, d1) + leucovorin (LV) (400 mg/m², Q3W, d1) + 5-fluorouracil (5-FU) (2400 mg/m², Q3W, continuous infusion for 46 hours). The treatment cycle is 21 days, continuing until disease progression, intolerable toxicity, the investigator determines that the participant no longer benefits, the participant withdraws informed consent, QL1706 treatment is completed for 2 years, or other reasons specified in the protocol.Other Name:	Drug	Experimental

Primary outcome

Median progression-free survival
Time frame: 1 year

7 secondary outcomes

Objective response rate ,ORR
Time frame: 1 year
Disease Control Rate
Time frame: 1 year
Duration Of Response
Time frame: 1 year
Overall survival ,OS
Time frame: up to 5 years after treatment discontinuation
12-month survival rate
Time frame: 12-month
24-month survival rate
Time frame: 24-month
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From ICF through 100 days after the last dose of study treatment

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yanhong Gu contact

+025-68307881

YanhongGu@njmu.edu.cn

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 19 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Yanhong Gu (+025-68307881, YanhongGu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median progression-free survival (time frame: 1 year). 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 NCT07400315.

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 10 Feb 2026.