MSI-H/dMMR advanced gastric cancer
Conditions
Interventions
Experimental group:Camrelizumab + Oxaliplatin + 5-FU or Capecitabine or Tegafur
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, regardless of gender; 2. Diagnosed as gastric cancer by histology or cytology, with measurable tumor lesions (spiral CT or MR scan >= 10 mm, meeting RECIST 1.1 standard); 3. Have not received systemic treatment; 4. The patient is intolerant or refuses to accept surgery; 5. Biopsy tissue immunohistochemistry (IHC) showed mismatch repair defects (dMMR) or gene sequencing results MSI status is microsatellite highly unstable (MSI-H); 6. HER2 is negative. HER2 negative is defined as: IHC (0 or 1+) or fluorescence in situ hybridization (FISH) negative (HER2: CEP17 ratio 3 months; 9. ECOG PS score: 0-1 points; 10. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors during screening): (1) The absolute count of neutrophils >= 1.5 x 10^9/L; platelets >= 80 x 10^9/L; hemoglobin >= 8.5 g/dL; (2) Thyroid-stimulating hormone (TSH) <= 1 x ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group); (3) Bilirubin <= 1.5 x ULN; ALT and AST <= 5 x ULN; (4) Serum creatinine <= 1.5 x ULN; 11. Women of childbearing age must take a negative pregnancy test (ßHCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to be effective contraceptive measures during treatment and 6 months after the last therapeutic dose; 12. The subject voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. History of other malignant tumors in the past 5 years; 3. A history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severely impaired lung function; 5. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment can be selected (such as vitiligo, psoriasis, or hair loss); 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery; 7. Severe active infection that requires intravenous antibiotic treatment during the screening period; 8. Those who are allergic to test drugs; 9. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Carrelizumab; 10. Known history of HIV infection; 11. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 12. The researcher believes that it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of 12-month PFS(Progress-Free Survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(Objective Response Rate);DCR(Disease Control Rate);OS(Overall Survival);PFS(Progress-Free Survival);Safety; | — |
Countries
China
Contacts
Public ContactHan Yu
Harbin Medical University Cancer Hospital
Outcome results
None listed