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New treatment option for Gastric Cancer
Official title PD-1 Antibody Carilizumab Combined with Apatinib for Unresectable Stage III and IV DMMR Gastric Cancer
ClinicalTrials.gov ID: NCT06792162
What this study is testing
What is Carilizumab and Apatinib?
Carilizumab and Apatinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Also referred to as PD-1 antibody.
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
- Evaluate the safety and efficacy of PD-1 antibody Carilizumab combined with apatinib for the conversion therapy of unresectable stage III and IV dMMR gastric cancer.
- 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 and older
You may be able to join if
- Age greater than or equal to 18 years old, gender not limited;
- Histologically confirmed unresectable stage III and IV dMMR (complete loss of at least one protein, MLH1, PMS2, MSH2, and MSH6), gastric...
- Unresectable gastric cancer patients with potential for conversion therapy, defined as gastric cancer patients with single organ metastasis (such as...
- Without surgery, radiation therapy, or immunotherapy for the gastric cancer lesion or metastatic tumor.
- ECOG PS score 0-1 points;
You likely can't join if
- Other malignant tumors have been diagnosed within 5 years before the first use of the investigational drug, except for effectively treated skin basal...
- Suffering from any active autoimmune disease or history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis...
- People with congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA ≥...
- Within 14 days prior to the first use of the investigational drug, immunosuppressive drugs have been used, excluding nasal and inhaled...
- Vaccination with attenuated live vaccine within 4 weeks before the first administration or planned during the study period;
- Patients with hypertension who cannot be reduced to normal range by antihypertensive medication (systolic blood pressure ≤ 140 mmHg/diastolic blood...
See the full eligibility criteria
- Age greater than or equal to 18 years old, gender not limited;
- Histologically confirmed unresectable stage III and IV dMMR (complete loss of at least one protein, MLH1, PMS2, MSH2, and MSH6), gastric adenocarcinoma (GC) (excluding neuroendocrine tumors) or gastroesophageal junction...
- Unresectable gastric cancer patients with potential for conversion therapy, defined as gastric cancer patients with single organ metastasis (such as liver metastasis, ovarian metastasis, lung metastasis)...
- Without surgery, radiation therapy, or immunotherapy for the gastric cancer lesion or metastatic tumor.
- ECOG PS score 0-1 points;
- Expected survival period ≥ 3 months;
- The main organ functions are normal, and there are no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency diseases.
- Normal coagulation function, no active bleeding or thrombotic diseases:
- The time from the end of traditional Chinese medicine, traditional Chinese patent medicines and simple preparations and immunomodulator (such as thymosin, interleukin, etc.) that have used anti-tumor drugs in the past...
- Non surgical sterilization or female people of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment...
- people voluntarily participated in this study, fully understood and informed of the study, and signed the Informed Consent Form (ICF);
- Other malignant tumors have been diagnosed within 5 years before the first use of the investigational drug, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma and/or effectively...
- Suffering from any active autoimmune disease or history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism...
- People with congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA...
- Within 14 days prior to the first use of the investigational drug, immunosuppressive drugs have been used, excluding nasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e. not...
- Vaccination with attenuated live vaccine within 4 weeks before the first administration or planned during the study period;
- Patients with hypertension who cannot be reduced to normal range by antihypertensive medication (systolic blood pressure ≤ 140 mmHg/diastolic blood pressure ≤ 90 mmHg);
- Suffering from uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA class II or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) poorly controlled arrhythmia;
- Patients who have had or currently have interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, etc., and whose lung function is severely impaired, which may interfere with the detection...
- suffer from active pulmonary tuberculosis;
- Severe infection (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first medication, or unexplained fever (body temperature ≥ 38.5 ° C) during the screening...
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Those who are known to have a history of allergies to the components of this drug regimen;
- There is a possibility of increasing participation in research and medication risks, or other severe, acute, and chronic diseases
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.