Gastric / Gastroesophageal Junction AdenocarcinomaPhase 2NCT07127822
Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H/dMMR Gastric Cancer
A Phase 2 study testing Iparomlimab and Tuvonralimab and First line chemotherapy plus PD-1/PD-L1 antibody in people with Gastric / Gastroesophageal Junction Adenocarcinoma and MSI-H Cancer, run by Peking University at 10 sites in China.
Trial summary
A randomized controlled phase II study exploring first-line treatment options for recurrent/metastatic MSI-H gastric cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric / Gastroesophageal Junction Adenocarcinoma, MSI-H Cancer
- What is being tested?
- Iparomlimab and Tuvonralimab and First line chemotherapy plus PD-1/PD-L1 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 10 sitesChina
- Study dates
- 15 Dec 2025to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Voluntarily willing to participate in the study and sign the written informed consent form 2. Age ≥18 years male or female . 3. Expected survival time ≥ 3 months 4. Patients with unresectable locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma diagnosed by histological or cytological examination: 5. Confirmed by PCR or next-generation sequencing(NGS) as microsatellite instability-high(MSI-H) . Patients with mismatch repair defecient identified by immunohistochemistry need to undergo PCR/NGS verification as MSI-H before treatment 6. Patients should not receive systematic anti-tumor treatment before, and for those who have received induction chemotherapy, concurrent radiochemotherapy, or neoadjuvant/adjuvant chemotherapy for curative purposes, the recurrence time must be at least 6 months from the end of the last treatment; 7. Agree to provide archived tumor tissue specimens or fresh tissue samples of primary or metastatic lesions within 3 years; If the patinet is unable to provide tumor tissue samples, they can be enrolled after evaluation by the researcher, provided that they meet other inclusion and exclusion criteria; 8. Patients must have at least one measurable lesion defined by RECIST 1.1. 9. European Cooperative Oncology Group (ECOG) ≤1 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥ 50%; 11. Patients must meet the following criteria at screening and before preconditioning (baseline). If any laboratory test result is abnormal referring to the following criteria,
- Hematology: neutrophils (NE) ≥1.5×109 per liter, , platelets (PLT) ≥100×109per liter and hemoglobin (Hb) ≥8.0 g/dL.
- Blood chemistry: creatinine clearance ≥50 mL/min, Creatinine (Cr) ≤ 1.5 × ULN, alanine aminotransferase (ALT) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, aspartate aminotransferase (AST) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, total bilirubin (TB) ≤1.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 3 × ULN）,
- International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 12. Urinary protein ≤ 2+or < 1000mg/24h; 13. Women of childbearing potential must have negative serum pregnancy test result at screening and before preconditioning and agree to use an effective and reliable contraceptive method for at least 1 year after the last study treatment. Te acceptable methods include bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion; any approved oral, injection or implantation of hormone; or barrier contraceptive method: condoms containing spermicidal .
Who cannot join
- Pregnant or lactating women.
- Previous use of PD-1/PD-L1 monoclonal antibodies, CTLA-4 monoclonal antibodies, or monoclonal and bispecific drugs containing the aforementioned targets;
- Existence of any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma in which subjects require bronchodilators for medical intervention cannot be included); However, the following diseases are allowed to be included: vitiligo, psoriasis, alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement treatment;
- Patients who require immunosuppressive therapy, systemic or absorbable local hormone therapy to achieve immunosuppressive goals (calculated as prednisone, dose>10mg/day or other therapeutic hormones) and continue to use it within 2 weeks of the first administration;
- Patients with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
- Patients with uncontrollable symptoms of brain metastasis, spinal cord compression, malignant meningitis, or brain or pia mater diseases detected by CT or MRI examination during screening within 4 weeks before the first administration
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- Patients who have received non systematic anti-tumor therapy within 3 weeks prior to the start of treatment, including but not limited to surgery, radiation therapy, interventional therapy, and anti-tumor traditional Chinese medicine treatment (based on the indications in the Chinese medicine instructions, and may also be enrolled after a 2-week washout period). Patients whose adverse events caused by previous treatment (excluding hair loss) have not recovered to ≤ CTCAE grade 2 are not within the above range;
- Patients with any severe and/or uncontrolled illnesses, including:
- 1) Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg) 2) Patients who experience unstable angina, myocardial infarction, ≥ grade 2 congestive heart failure, or arrhythmia requiring treatment within 6 months of initial administration (including QTc ≥ 480ms); 3) Active or uncontrolled severe infection (≥ CTCAE grade 2 infection); 4) A history of clinically significant liver disease, including viral hepatitis, known as a carrier of hepatitis B virus (HBV), must exclude active HBV infection, i.e. HBV DNA positive (>2000 IU/mL); Known hepatitis C virus infection (HCV) and HCV RNA positivity (>1 × 103 copies/mL), or other decompensated liver diseases or chronic hepatitis requiring antiviral therapy; 5) HIV test positive 6) Poor control of diabetes (fasting blood glucose ≥ CTCAE level 2); 9. Patients who have experienced severe infections (CTCAE>grade 2) within the first 4 weeks of randomization, such as severe pneumonia, bacteremia, sepsis, tuberculosis, etc; Indications of pulmonary infection or active pulmonary inflammation within the first 2 weeks of randomization; 10. Patients with a history of allergies to recombinant humanized antibodies who are allergic to any excipient components of the drug; 11. History of autologous or allogeneic stem cell transplantation; 12. Patients with a history of serious neurological or psychiatric disorders, including but not limited to: dementia, depression, epileptic seizures, bipolar disorder, etc; 13. Patients diagnosed as active malignant tumor within the first 3 years of randomization, except for the following cases: radical skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ and/or radical resection of carcinoma in situ, which the researchers think can be included; 14. Patients who plan to receive live vaccines within 28 days prior to randomization; 15. Researchers evaluate situations where participation in this clinical trial is inappropriate due to complications or other reasons.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Department of GI Oncology, Peking University Cancer Hospital
Beijing
Lin Shen, (86)10-88196561, linshenpku@163.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Hongfeng Gou, 86-028-85422114
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Guangyu Wang, 86-0451-86298000
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Hao Wu, 86-025-83714511
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Zi min Liu, 86-0532-96166
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Fengbin Zhang, 86-0311-86095588
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Hongxia Lu, 86-0351-4651714
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Ting Deng, 86-022-23340123
- Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University）
Xi'an, Shaanxi
Yuying Wu, 86-029-85323338
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yongxu Jia, 86-0371-66913114
About this study
Official title: A Randomized, Controlled, Multi-centers, Non Inferiority Phase II Clinical Study Comparing Iparomlimab and Tuvonralimab With Standard Chemotherapy Combined With PD-1/PD-L1 Monoclonal Antibody as First-line Treatment for MSI-H/dMMR Recurrent/Metastatic Gastric Cancer
A randomized controlled phase II study exploring first-line treatment options for recurrent/metastatic MSI-H gastric cancer
Read the detailed description
This is a randomized controlled, non-inferiority design phase II study in the first-line treatment of recurrent/metastatic MSI-H gastric cancer, using iparomlimab and tuvonralimab and standard first-line chemotherapy combined with PD-1/PD-L1 antibody in two cohorts, respectively,
- Being tested
- Iparomlimab and Tuvonralimab, First line chemotherapy plus PD-1/PD-L1 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and TuvonralimabDrug
Iparomlimab and tuvonralimab for experimental arm
First line chemotherapy plus PD-1/PD-L1 antibodyDrug
standard first-line chemotherapy（FOLFOX/XELOX/SOX）combined with PD-1/PD-L1 antibody for control arm
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | iparomlimab and tuvonralimab Receives: Drug: Iparomlimab and Tuvonralimab |
| Control arm | Active comparator | standard first-line chemotherapy（FOLFOX/XELOX/SOX） combined with PD-1/PD-L1 antibody Receives: Drug: First line chemotherapy plus PD-1/PD-L1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor efficacy-Objective response rate (ORR)
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%).
Measured: 2 years
Secondary outcomes (5)
Antitumor efficacy-Progression-free survival (PFS)
The period from the day of randomization to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.
Measured: 2 years
Antitumor efficacy-Overall survival (OS)
The period from the day of randomization to any cause of death
Measured: 2 yeas
Treatment related AEs
Measured: 2 years
Antitumor efficacy-Duration of response (DOR)
The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause
Measured: 2 years
Antitumor efficacy-Time to response (TTR)
Time from randomization to first recording of PR or CR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start15 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric / Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Qilu Pharmaceutical Group Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127822
- Sponsor's protocol ID
- PUCH MSI-H GC 1st
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 5 Aug 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-centers, Non Inferiority Phase II Clinical Study Comparing Iparomlimab and Tuvonralimab With Standard Chemotherapy Combined With PD-1/PD-L1 Monoclonal Antibody as First-line Treatment for MSI-H/dMMR Recurrent/Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT07127822
- Acronym / sponsor ID
- PUCH MSI-H GC 1st
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Qilu Pharmaceutical Group Co., Ltd
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Aug 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.
A randomized controlled phase II study exploring first-line treatment options for recurrent/metastatic MSI-H gastric cancer
Detailed description
This is a randomized controlled, non-inferiority design phase II study in the first-line treatment of recurrent/metastatic MSI-H gastric cancer, using iparomlimab and tuvonralimab and standard first-line chemotherapy combined with PD-1/PD-L1 antibody in two cohorts, respectively,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Iparomlimab and Tuvonralimabiparomlimab and tuvonralimab |
| Control arm | Active comparator | Drug: First line chemotherapy plus PD-1/PD-L1 antibodystandard first-line chemotherapy（FOLFOX/XELOX/SOX） combined with PD-1/PD-L1 antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Voluntarily willing to participate in the study and sign the written informed consent form 2. Age ≥18 years male or female . 3. Expected survival time ≥ 3 months 4. Patients with unresectable locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma diagnosed by histological or cytological examination: 5. Confirmed by PCR or next-generation sequencing(NGS) as microsatellite instability-high(MSI-H) . Patients with mismatch repair defecient identified by immunohistochemistry need to undergo PCR/NGS verification as MSI-H before treatment 6. Patients should not receive systematic anti-tumor treatment before, and for those who have received induction chemotherapy, concurrent radiochemotherapy, or neoadjuvant/adjuvant chemotherapy for curative purposes, the recurrence time must be at least 6 months from the end of the last treatment; 7. Agree to provide archived tumor tissue specimens or fresh tissue samples of primary or metastatic lesions within 3 years; If the patinet is unable to provide tumor tissue samples, they can be enrolled after evaluation by the researcher, provided that they meet other inclusion and exclusion criteria; 8. Patients must have at least one measurable lesion defined by RECIST 1.1. 9. European Cooperative Oncology Group (ECOG) ≤1 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥ 50%; 11. Patients must meet the following criteria at screening and before preconditioning (baseline). If any laboratory test result is abnormal referring to the following criteria,
- Hematology: neutrophils (NE) ≥1.5×109 per liter, , platelets (PLT) ≥100×109per liter and hemoglobin (Hb) ≥8.0 g/dL.
- Blood chemistry: creatinine clearance ≥50 mL/min, Creatinine (Cr) ≤ 1.5 × ULN, alanine aminotransferase (ALT) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, aspartate aminotransferase (AST) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, total bilirubin (TB) ≤1.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 3 × ULN）,
- International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 12. Urinary protein ≤ 2+or < 1000mg/24h; 13. Women of childbearing potential must have negative serum pregnancy test result at screening and before preconditioning and agree to use an effective and reliable contraceptive method for at least 1 year after the last study treatment. Te acceptable methods include bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion; any approved oral, injection or implantation of hormone; or barrier contraceptive method: condoms containing spermicidal .
Key exclusion criteria (9 listed)
- Pregnant or lactating women.
- Previous use of PD-1/PD-L1 monoclonal antibodies, CTLA-4 monoclonal antibodies, or monoclonal and bispecific drugs containing the aforementioned targets;
- Existence of any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma in which subjects require bronchodilators for medical intervention cannot be included); However, the following diseases are allowed to be included: vitiligo, psoriasis, alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement treatment;
- Patients who require immunosuppressive therapy, systemic or absorbable local hormone therapy to achieve immunosuppressive goals (calculated as prednisone, dose>10mg/day or other therapeutic hormones) and continue to use it within 2 weeks of the first administration;
- Patients with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
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 TuvonralimabIparomlimab and tuvonralimab for experimental arm | Drug | Experimental arm |
| First line chemotherapy plus PD-1/PD-L1 antibodystandard first-line chemotherapy（FOLFOX/XELOX/SOX）combined with PD-1/PD-L1 antibody for control arm | Drug | Control arm |
Primary outcome
Antitumor efficacy-Objective response rate (ORR)
Time frame: 2 years
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%).
5 secondary outcomes
Antitumor efficacy-Progression-free survival (PFS)
Time frame: 2 years
Antitumor efficacy-Overall survival (OS)
Time frame: 2 yeas
Treatment related AEs
Time frame: 2 years
Antitumor efficacy-Duration of response (DOR)
Time frame: 2 years
Antitumor efficacy-Time to response (TTR)
Time frame: 2 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 5 Aug 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab and First line chemotherapy plus PD-1/PD-L1 antibody in people with Gastric / Gastroesophageal Junction Adenocarcinoma and MSI-H Cancer, run by Peking University at 10 sites 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 4 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Contact Lin Shen (（86）10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antitumor efficacy-Objective response rate (ORR) (time frame: 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 5 Aug 2026.