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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

A Prospective, Single-Center, Exploratory Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy in the Treatment of Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer (NCT07315854) is a Phase 2 interventional studying Gastric Cancer (GC) and Gastroesophageal Junction Cancer, sponsored by Beijing Friendship Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer. The main questions it aims to answer are: 1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will: 1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks. 2. Receive SOX chemotherapy (Oxaliplatin via intravenous infusion on Day 1 and S-1 orally twice daily for 14 days) every 3 weeks for up to 6 cycles. 3. Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity. 4. Undergo tumor imaging assessments (CT or MRI) every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter to monitor the disease.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Cancer (GC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 32 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the willing to sign a consent form Form (ICF); willing to follow and able to complete all trial procedures. - Age 18-80 years, gender is not limited. - Patients with locally advanced unresectable, recurrent unresectable, or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC) confirmed by imaging and other examinations, and histopathologically confirmed as adenocarcinoma. - Provide a report confirming HER2 overexpression or amplification negativity; defined as IHC 0/1+, or IHC 2+ with FISH/ISH negative. - No previous cancer treatment that works throughout the body (like chemotherapy) for advanced or metastatic GC/GEJC (including anti-HER-2 therapy). Patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy, or chemoradiotherapy) for GC/GEJC are eligible if the time to first recurrence or disease progression is greater than 6 months from the end of the last treatment. Prior use of anti-tumor Traditional Chinese Medicine preparations is allowed but must be discontinued at least 2 weeks before enrollment. - ECOG performance status score of 0 or 1. - Must have at least one measurable lesion according to RECIST v1.1 definitions. - All acute toxicities caused by prior anti-tumor therapy or surgery must have resolved to Grade 0-1 (according to NCI CTCAE v5.0) or to the level specified in the inclusion/exclusion criteria. Alopecia, fatigue, and hearing loss, or other toxicities considered by the investigator not to pose a safety risk to the subject, are excluded. - your organs (liver, kidneys, etc.) are working well enough based on blood tests (laboratory tests within 7 days prior to treatment): - Hematology (No blood transfusion, G-CSF use, or drug correction within 14 days prior to screening): - White blood cell count (WBC) ≥ 3,000/mm³ (3.0 × 10⁹/L); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures. * Age 18-80 years, gender is not limited. * Patients with locally advanced unresectable, recurrent unresectable, or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC) confirmed by imaging and other examinations, and histopathologically confirmed as adenocarcinoma. * Provide a report confirming HER2 overexpression or amplification negativity; defined as IHC 0/1+, or IHC 2+ with FISH/ISH negative. * No prior systemic therapy for advanced or metastatic GC/GEJC (including anti-HER-2 therapy). Patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy, or chemoradiotherapy) for GC/GEJC are eligible if the time to first recurrence or disease progression is greater than 6 months from the end of the last treatment. Prior use of anti-tumor Traditional Chinese Medicine preparations is allowed but must be discontinued at least 2 weeks before enrollment. * ECOG performance status score of 0 or 1. * Must have at least one measurable lesion according to RECIST v1.1 definitions. * All acute toxicities caused by prior anti-tumor therapy or surgery must have resolved to Grade 0-1 (according to NCI CTCAE v5.0) or to the level specified in the inclusion/exclusion criteria. Alopecia, fatigue, and hearing loss, or other toxicities considered by the investigator not to pose a safety risk to the subject, are excluded. * Adequate organ function (laboratory tests within 7 days prior to treatment): * Hematology (No blood transfusion, G-CSF use, or drug correction within 14 days prior to screening): * White blood cell count (WBC) ≥ 3,000/mm³ (3.0 × 10⁹/L); * Absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L); * Platelet count (PLT) ≥ 100,000/mm³ (100 × 10⁹/L); * Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L). * Biochemistry (No albumin transfusion within 14 days prior to screening): * Albumin ≥ 3.0 g/dL (30 g/L); * Creatinine ≤ 1.5 × Upper Limit of Normal (ULN) or Creatinine Clearance ≥ 50 ml/min (calculated using the Cockcroft-Gault formula); * Total Bilirubin (BIL) ≤ 1.5 × ULN; * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels ≤ 2.5 × ULN; for patients with liver metastases, ≤ 5 × ULN. * Coagulation: International Normalized Ratio (INR) ≤ 1.5, Prothrombin Time (PT), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. * Urine: Urine protein \< 2+; if urine protein is ≥ 2+, 24-hour urine protein quantification must be ≤ 1g. * Life expectancy ≥ 3 months. * Women of childbearing potential must undergo a serum or urine pregnancy test within 7 days before starting treatment, with a negative result, and must not be lactating. All enrolled patients must use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: * Known squamous cell carcinoma, undifferentiated carcinoma, other histological types of gastric cancer, or mixed gastric cancer containing other histological types. * Active malignant tumors within the past 2 years, other than the tumor under study. Exceptions include subjects with locally curable cancers (that have been cured), such as basal or squamous cell skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix or breast. * Participation in a study of an investigational drug or receipt of investigational treatment or use of an investigational device within 4 weeks prior to the first dose. * Enrollment in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study (defined as \>4 weeks since the last dose of the previous clinical study or \>5 half-lives of the study drug). * Untreated Central Nervous System (CNS) metastases, or uncontrolled or symptomatic active CNS metastases. Patients with fully treated CNS metastases may be enrolled if neurological symptoms have returned to baseline levels at least 4 weeks prior to enrollment (excluding residual signs or symptoms related to CNS treatment). Additionally, subjects must have discontinued corticosteroids or be on a stable or tapering dose of prednisone ≤ 10 mg/d (or equivalent dose of other corticosteroids) for at least 4 weeks prior to enrollment. * Pleural effusion or ascites that remains uncontrolled despite puncture and drainage within 14 days prior to enrollment; symptomatic or moderate-to-large pericardial effusion. * Weight loss of more than 20% within 2 months prior to enrollment. * Received the following treatments or medications prior to enrollment: * Major surgery within 28 days prior to enrollment (tissue biopsy for diagnosis and PICC/port implantation are allowed). * Use of immunosuppressive drugs within 14 days prior to enrollment, excluding nasal/inhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤ 10 mg/d prednisone or equivalent). * Vaccination with live attenuated vaccines within 28 days prior to enrollment or planned during the study period and within 60 days after the end of study drug treatment. * Local anti-tumor therapy (e.g., radiotherapy or tumor embolization) within 28 days prior to enrollment. * Diagnosed with any other malignant tumor within 5 years prior to entering the study, except for cured cutaneous basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma amenable to local treatment. * Presence of any active, known, or suspected autoimmune disease. Subjects in a stable state not requiring systemic immunosuppressive therapy are allowed, such as Type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia). * Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. * Significant clinical bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment; gastrointestinal perforation and/or fistula within 6 months prior to enrollment; arterial/venous thromboembolic events within 6 months prior to enrollment, such as cerebrovascular accident (including TIA, cerebral infarction), deep vein thrombosis, and pulmonary embolism (except for those with gastric cancer bleeding/perforation where symptoms disappeared after surgical resection). * Major vascular disease within 6 months before the start of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis). * Severe, unhealed, or dehisced wounds, active ulcers, or untreated fractures. * Presence of \> Grade 1 peripheral neuropathy. * History of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting study treatment, including incomplete obstruction related to the underlying disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. Patients with incomplete obstruction/obstruction syndrome at initial diagnosis who have symptom relief after definitive (surgical) treatment may be enrolled. * Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia, etc.). * Known history of active tuberculosis. * Known allergy to the study drug or any of its excipients; or history of severe allergic reactions to other monoclonal antibodies. * HIV infection or known Acquired Immunodeficiency Syndrome (AIDS); untreated active hepatitis (Hepatitis B defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C defined as anti-HCV positive and HCV RNA above the lower limit of detection) or co-infection with Hepatitis B and C. * Poorly controlled clinical cardiac symptoms or diseases, such as: (1) NYHA Class II or higher cardiac insufficiency or LVEF \< 50% on echocardiography; (2) Severe/unstable angina; (3) Myocardial infarction within 12 months prior to enrollment; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) Symptomatic congestive heart failure; (6) QTc \> 480 ms. * Systemic use of antibiotics ≥ 7 days within 4 weeks prior to enrollment, or unexplained fever \> 38.5°C during screening/before first dose (fever due to tumor causes is allowed per investigator judgment). * Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Participation in any other drug clinical study within 4 weeks or 5 half-lives prior to enrollment. * Known history of psychotropic drug abuse or drug addiction. * Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of participation, interfere with study results, or render the patient unsuitable for the study in the opinion of the investigator.

Treatments Being Tested

DRUG

Iparomlimab and Tuvonralimab (QL1706)

Administered via intravenous (IV) infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.

DRUG

SOX Chemotherapy

Oxaliplatin: 130mg/m2, iv.gtt, single infusion, 21 days as a cycle, Day 1. Tigio: 40mg (body surface area(BSA)\<1.25m2), 50mg (BSA≥1.25m2, and BAS\<1.5m2), 60mg (BSA ≥1.5m2), p.o, bid, 21 days as a cycle, Day 1-14.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07315854), the sponsor (Beijing Friendship Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07315854 clinical trial studying?

The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer. The main questions it aims to answer are: 1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will: 1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 wee… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07315854?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07315854?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07315854. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07315854. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.