Gastric cancer
Conditions
Interventions
Therapy group:camrelizumab and apatinib
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years old, gender not limited; 2. 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 adenocarcinoma (GEJ); 3.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), retroperitoneal lymph node metastasis, supraclavicular lymph node metastasis, localized peritoneal metastasis, invasion of surrounding organs, and other gastric cancer patients evaluated by researchers as feasible for conversion therapy; 4. Without surgery, radiation therapy, or immunotherapy for the gastric cancer lesion or metastatic tumor. 5. ECOG PS score 0-1 points; 6. Expected survival period >= 3 months; 7. The main organ functions are normal, and there are no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency diseases. 8. Normal coagulation function, no active bleeding or thrombotic diseases: 9. 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 to the start of the study must be >= 2 weeks; 10. Non surgical sterilization or female subjects of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 180 days after the end of the study treatment; Female subjects of childbearing age who undergo non-surgical sterilization must have a negative serum HCG test within 72 hours prior to randomization; And it must be during non lactation period; For male participants whose partners are women of childbearing age, effective contraception methods should be used during the study treatment period and within 180 days after the end of the study treatment period. 11 Subjects voluntarily participated in this study, fully understood and informed of the study, and signed the Informed Consent Form (ICF); 12. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol; 13. Have sufficient samples for exploratory studies.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed within 5 years prior to the first use of the study drug, except for malignancies with long-term survival such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or in situ cervical cancer and/or breast cancer and/or thyroid cancer that have been effectively treated; 2. Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy; 3. Have any active autoimmune disease or history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (except for patients with stable hormone levels after treatment); Subjects with childhood asthma who have been in complete remission and do not require any intervention in adulthood or vitiligo may be included, but participants requiring medical intervention with bronchodilators cannot be included; 4. Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and hepatitis C; 5. Use of immunosuppressive medications, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day prednisolone or other corticosteroids at equivalent pharmacophysiological doses) within 14 days prior to the first dose of study drug; 6. Vaccination with live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study; 7. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure = 38.5°C) during screening/before the first dose; 13. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. Subjects with brain metastases; 15. Those who are known to have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of 1 year Progression Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Main Pathological Response Rate (MPR);Margin-free (R0) resection rate;Overall survival (OS) ;Objective response rate (ORR);Disease control rate (DCR);Averse event (AE) and serious averse event (SAE); | — |
Countries
China
Contacts
Public ContactBaoshan Cao
Peking University Third Hospital
Outcome results
None listed