Clin2
NCT07776639Worth exploringRecruiting

Immunotherapy with chemotherapy before surgery for stomach cancer

Gastroesophageal Junction AdenocarcinomaGastric Adenocarcinoma

Treatments studied

This trial tests whether adding an immunotherapy drug (QL1706) to a standard chemotherapy regimen, given before surgery, can help shrink stomach or gastroesophageal junction cancer. The goal is to improve the chance of successful surgery and long-term outcomes.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
34 people
Ages
18 years to 75 years
Study type
Interventional

Who can take part

  • You are between 18 and 75 years old.
  • You have been diagnosed with stomach or gastroesophageal junction cancer that has not spread to other organs and can be surgically removed.
  • You have not had any prior cancer treatment, including immunotherapy.
  • You are in generally good health, with adequate organ function.
  • You are willing to use effective birth control during the study and for 6 months after treatment.
  • You have not had any other cancer in the past 5 years, except for certain non-invasive cancers.
  • You do not have active autoimmune disease or a condition requiring long-term steroids.
  • You do not have a history of intestinal blockage or significant bleeding.
  • You have not had major surgery within the last 4 weeks.
  • You are not pregnant or breastfeeding.
  • You do not have a history of interstitial lung disease or active infection.
  • You do not have any other medical condition that, in the investigator's opinion, would make you unsuitable for the study.
  • You understand and sign the informed consent form.
  • You have adequate liver, kidney, and bone marrow function as confirmed by blood tests.
  • You have an ECOG performance status of 0 or 1 (meaning you are fully active or restricted in physically strenuous activity but ambulatory).
  • You have not had a blood transfusion within 14 days before the blood test.
  • You have a left ventricular ejection fraction (LVEF) of at least 50%.
  • Your thyroid stimulating hormone (TSH) level is within normal range.
  • You agree not to participate in another interventional clinical trial during the study.
  • You have not received a live vaccine within 4 weeks before the first dose.
  • You have not had an allergic reaction to any of the study drugs.
  • You do not have uncontrolled heart disease.
  • You have not had a severe infection within 4 weeks before the study.
  • You do not have active pulmonary tuberculosis.
  • You have not had any bleeding events of CTCAE Grade 3 or higher within 4 weeks before screening.
  • You have not received any other investigational drug within 4 weeks before the first dose.
  • You are willing to provide written informed consent.
  • You are able to tolerate oral medication.
  • You have no medical condition that would interfere with the study.
  • You agree to follow the study schedule and procedures.
  • You have not had a major surgery within 4 weeks before the first dose.
  • You do not have a history of non-infectious pneumonia.
  • You do not have a history of organ transplant.
  • You have not received a live vaccine within 30 days before the first dose.
  • You do not have a history of psychotropic drug abuse.
  • You do not have a history of alcohol or drug abuse that would interfere with the study.
  • You are not unable to take oral medications due to swallowing difficulties.
  • You do not have a history of severe allergic reactions to monoclonal antibodies.
  • You do not have a history of active tuberculosis.
  • You are not taking any medications that are contraindicated with the study drugs.
  • You have not had a bone marrow biopsy in the past 2 weeks.
  • You are not scheduled for a major surgery during the study.
  • You are not participating in another study that involves an investigational drug.
  • You have not had a blood transfusion within 7 days of the start of the study.
  • You agree to have a pregnancy test if you are a woman of childbearing potential.
  • You agree to use a condom if you are a man whose partner is of childbearing potential.
  • You agree to avoid becoming pregnant or fathering a child during the study.
  • You agree to inform the study doctor of any new medical condition.
  • You agree to report any adverse events to the study doctor.
  • You agree to allow the study team to collect your medical information.
  • You understand that your participation is voluntary and you can withdraw at any time.
  • You have read and understood the consent form.
  • You have had the opportunity to ask questions.
  • You agree to participate in the study.
  • You have received a copy of the consent form.
  • You understand that you will not be paid for participating in this study.
  • You agree to comply with the study requirements.
  • You have not been diagnosed with a mental illness that would interfere with the study.
  • You do not have a history of non-compliance with medical treatment.
  • You are not participating in any other clinical trial.
  • You have not had a fever within 24 hours of the first dose.
  • You have not had a history of blood clots in the veins or arteries within the past 6 months.
  • You have not had a stroke within the past 6 months.
  • You have not had a heart attack within the past 6 months.
  • You have not had uncontrolled high blood pressure.
  • You have not had a history of a bleeding disorder.
  • You have not had a history of a condition that causes poor absorption of food.
  • You have not had a history of a fistula in the abdomen.
  • You have not had a history of a perforation in the stomach or intestine.
  • You have not had a history of a severe skin reaction.
  • You have not had a history of a serious allergic reaction to a medication.
  • You are not pregnant, breastfeeding, or planning to become pregnant during the study.
  • You agree to use effective birth control from the time of signing the consent form until 6 months after the last dose of study drug.
  • You have not had any known allergies to any excipients.
  • You have not had a history of a stroke or transient ischemic attack within the past 6 months.
  • You have not had a history of a heart attack within the past 6 months.
  • You have not had a history of unstable angina within the past 6 months.
  • You have not had a history of congestive heart failure within the past 6 months.
  • You have not had a history of a serious cardiac arrhythmia within the past 6 months.
  • You have not had a history of a pulmonary embolism within the past 6 months.
  • You have not had a history of deep vein thrombosis within the past 6 months.
  • You have not had

View the official record on ClinicalTrials.gov

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