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New treatment option for Gastric Cancers
Official title QL1706 Combined With SOX Used in Theperioperative Treatment
ClinicalTrials.gov ID: NCT06766305
What this study is testing
What is QL1706 combined with SOX?
QL1706 combined with SOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancers.
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
- This is a single-center, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study consists of the following two phases: Phase 1: The safety introduction phase of QL1706 combined with SOX, using a 3+3 design, enrolled about 6 to 12 patients with locally advanced gastric/gastroesophageal junction adenocarcinoma (primary clinical stage ≥T3 or N+, M0) and underwent 3-week DLT evaluation.
- 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 75
You may be able to join if
- Sign a written informed consent to join the study voluntarily;
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
- Adenocarcinoma of the stomach or gastroesophageal junction was evaluated by CT/MRI (primary clinical stage ≥T3 or N+, M0, according to AJCC 8th...
- Age 18-75 years old, male or female;
- ECOG PS 0-1 ;
You likely can't join if
- There are unresectable factors, including unresectable tumor causes or unresectable or refused surgery contraindications;
- Have received or are receiving any of the following treatment:
- any radiation therapy, chemotherapy, or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies...
- being treated with immunosuppressive drugs or systemic hormones for immunosuppressive purposes within 2 weeks prior to the initial use of the...
- Received live attenuated vaccine within 4 weeks prior to the first use of the investigational drug; If enrolled, people must not receive live vaccine...
- Serious infections (CTCAE \> Grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and...
See the full eligibility criteria
Who can join
- Sign a written informed consent to join the study voluntarily;
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
- Adenocarcinoma of the stomach or gastroesophageal junction was evaluated by CT/MRI (primary clinical stage ≥T3 or N+, M0, according to AJCC 8th edition staging), including Siewert type II and III tumors
- Age 18-75 years old, male or female;
- ECOG PS 0-1 ;
- Have not received any anti-tumor treatment for gastric or gastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, surgery, etc.;
- Surgical treatment is planned after the completion of neoadjuvant therapy, and R0 resection is expected;
- Expected survival ≥6 months;
- Normal functioning of major organs, including:
- Blood routine examination (no blood component, cell growth factor are allowed within 7 days before the first use of the study drug) : neutrophil count ≥ 1.5×109/L Platelet count ≥ 80×109/L Hemoglobin ≥ 80 g/L
- Blood biochemical examination: Total bilirubin ≤ 1.5 x ULN ALT ≤ 2.5 x ULN, AST ≤ 2.5 x ULN, Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cocheroft-Gault formula)
- Coagulation function: International Standardized ratio (INR) ≤ 1.5 x ULN Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN
- Fertile female people are required to take a serum or urine pregnancy test that is negative within 72 hours prior to the start of the study drug administration, and to use effective contraception (such as Iuds...
- The subject have good compliance and cooperated well with the follow-up
- Agreed to provide tumor tissue samples
What rules you out
- There are unresectable factors, including unresectable tumor causes or unresectable or refused surgery contraindications;
- Have received or are receiving any of the following treatment:
- any radiation therapy, chemotherapy, or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) and other anti-tumor drugs;
- being treated with immunosuppressive drugs or systemic hormones for immunosuppressive purposes within 2 weeks prior to the initial use of the investigational drug (dose \>10mg/ day prednisone or equivalent); In the...
- Received live attenuated vaccine within 4 weeks prior to the first use of the investigational drug; If enrolled, people must not receive live vaccine during the study period or within 120 days after the last...
- Serious infections (CTCAE \> Grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging...
- Patients with active autoimmune disease requiring systemic treatment within 2 years prior to initial use of the investigational drug or a history of autoimmune disease with recurrence possible [including but not limited...
- A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
- There are clinical symptoms or diseases of heart that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1...
- Patients found to have active pulmonary tuberculosis infection through medical history or CT examination, or had a history of active pulmonary tuberculosis infection within 1 year before enrollment, or had a history of...
- There are factors that increase the risk of prolonged QTc and abnormal heart rate, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death of...
- Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA≥2000 IU/ml; Hepatitis C reference: HCV antibody positive and HCV copy number \> upper limit of normal);
- Defined as ≥ grade 2 peripheral neuropathy according to NCI-CTCAE v5.0 standards;
- Have been diagnosed with other malignancies within 5 years prior to initial dosing, unless malignancies with a low risk of metastasis or death (5-year survival \> 90%), such as well-treated basal cell or squamous cell...
- Known history of severe hypersensitivity to other monoclonal antibodies; Patients with a known history of allergy or hypersensitivity to QL1706, oxaliplatin, and Tigor or any of their components;
- Known deficiency of dihydropyrimidine dehydrogenase;
- Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome that may affect the absorption of Tegor;
- Pregnant or lactating women;
- Enrolling in another clinical study at the same time, unless it is an observational, non-treatment clinical study or the follow-up period of an treatment study;
- The investigator determined that there were other factors that might have led to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, alcohol...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.