Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT07151209
Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Iparomlimab and Tuvonralimab combined with lenvatinib and SOX in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial 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 combined with lenvatinib and SOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2028
- 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
- Able to understand and agree to comply with study requirements and the assessment schedule, and voluntarily sign the written informed consent form (ICF) before any trial-related procedures are implemented;
- Age greater than 18 years, regardless of gender. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma.
- 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 6 months prior to the diagnosis of unresectable or metastatic disease.
- PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG performance status 0-1.
- Life expectancy >3 months.
- Adequate organ and marrow function:
Who cannot join
- 1. Known HER2-positive expression (immunohistochemistry [IHC] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).
- Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted).
- Known central nervous system metastases and/or carcinomatous meningitis.
- Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction.
- Hypertension that cannot be controlled with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
- History of bleeding within 4 weeks prior to screening, with any bleeding event graded as ≥3 according to CTCAE 5.0.
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- Thrombotic events (arterial or venous) within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (excluding previously thrombosed veins deemed healed by the investigator), and pulmonary embolism.
- History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
lin jun Wang contact
About this study
Official title: A Prospective, Multicenter, Open-label Phase II Single-arm Clinical Trial Protocol on the Efficacy and Safety of Lparomlimab and Tuvonralimab in Combination With Lenvatinib and SOX Chemotherapy in Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial
- Being tested
- Iparomlimab and Tuvonralimab combined with lenvatinib and SOX
- Keywords
- Iparomlimab and Tuvonralimab, lenvatinib, SOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab combined with lenvatinib and SOXDrug
Iparomlimab and Tuvonralimab:5 mg/kg Q3W lenvatinib:8 mg/day orally SOX：oxaliplatin (130 mg/m² Q3W intravenous infusion), and S-1 (40 mg/m² BID orally on days 1-14)
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab combination with lenvatinib and SOX | Experimental | Not described Receives: Drug: Iparomlimab and Tuvonralimab combined with lenvatinib and SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
Measured: Up to approximately 2 years
Secondary outcomes (7)
Major pathological response (MPR) rate
Measured: Up to approximately 2 years
R0 resection rate
Measured: Up to approximately 2 years
Objective response rate (ORR)
Measured: Up to approximately 2 years
Event-free survival (EFS)
Measured: Up to approximately 2 years
12-month, 24-month, and 36-month event-free survival rates Disease-free survival (DFS)
Measured: Up to approximately 3 years
Overall survival (OS)
Measured: Up to approximately 5 years
12-month, 24-month, and 36-month overall survival rates
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151209
- Sponsor's protocol ID
- QL-GasC-QIBA-3011
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label Phase II Single-arm Clinical Trial Protocol on the Efficacy and Safety of Lparomlimab and Tuvonralimab in Combination With Lenvatinib and SOX Chemotherapy in Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
- ClinicalTrials.gov ID
- NCT07151209
- Acronym / sponsor ID
- QL-GasC-QIBA-3011
- Keywords
- Iparomlimab and Tuvonralimab, lenvatinib, SOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Sep 2025 (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.
Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab combination with lenvatinib and SOX | Experimental | Drug: Iparomlimab and Tuvonralimab combined with lenvatinib and SOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand and agree to comply with study requirements and the assessment schedule, and voluntarily sign the written informed consent form (ICF) before any trial-related procedures are implemented;
- Age greater than 18 years, regardless of gender. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma.
- 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 6 months prior to the diagnosis of unresectable or metastatic disease.
- PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing.
- At least one measurable lesion according to RECIST 1.1 criteria.
Key exclusion criteria (9 listed)
- 1. Known HER2-positive expression (immunohistochemistry [IHC] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).
- Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted).
- Known central nervous system metastases and/or carcinomatous meningitis.
- Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction.
- Hypertension that cannot be controlled with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
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 combined with lenvatinib and SOXIparomlimab and Tuvonralimab:5 mg/kg Q3W lenvatinib:8 mg/day orally SOX：oxaliplatin (130 mg/m² Q3W intravenous infusion), and S-1 (40 mg/m² BID orally on days 1-14) | Drug | Iparomlimab and Tuvonralimab combination with lenvatinib and SOX |
Primary outcome
Pathological complete response (pCR) rate
Time frame: Up to approximately 2 years
7 secondary outcomes
Major pathological response (MPR) rate
Time frame: Up to approximately 2 years
R0 resection rate
Time frame: Up to approximately 2 years
Objective response rate (ORR)
Time frame: Up to approximately 2 years
Event-free survival (EFS)
Time frame: Up to approximately 2 years
12-month, 24-month, and 36-month event-free survival rates Disease-free survival (DFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 5 years
12-month, 24-month, and 36-month overall survival rates
Time frame: Up to approximately 3 years
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 3 Sep 2025.
- 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.
lin jun Wang contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab combined with lenvatinib and SOX in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University.
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 8 inclusion and 9 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 3 Sep 2025. 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 lin jun Wang (+8618795460898), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2025.