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New treatment option for Gastric Cancer (GC)
Official title Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
ClinicalTrials.gov ID: NCT07315854
What this study is testing
What is Iparomlimab and Tuvonralimab (QL1706)?
Iparomlimab and Tuvonralimab (QL1706) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for gastric cancer (gc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the Informed Consent Form (ICF); willing to...
- 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)...
- 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...
You likely can't join if
- . 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);
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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/
What rules you out
- . 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...
- 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 people with locally curable cancers (that have been cured), such as basal or squamous cell skin cancer, superficial...
- 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-treatment clinical study or the follow-up period of an treatment study (defined as \>4 weeks since the last dose of the previous clinical study or...
- 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...
- 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...
- Presence of any active, known, or suspected autoimmune disease. people in a stable state not requiring systemic immunosuppressive therapy are allowed, such as Type I diabetes, hypothyroidism requiring only hormone...
- 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...
- 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...
- 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...
- Poorly controlled clinical cardiac symptoms or diseases, such as: (1) NYHA Class II or higher cardiac insufficiency or LVEF \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.