advanced gastric cancer
Conditions
Interventions
Group A:Cadonilimab + albumin-bound paclitaxel +capecitabine + chidamide
Group B:Cadonilimab + oxaliplatin + capecitabine+ chidamide
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma. 2.>= 18 years old, gender unrestricted; 3.Expected survival >=3 months. 4.ECOG PS score: 0~1; 5.Subjects have at least one measurable tumor lesion per RECIST v1.1; 6.Unresectable locally advanced or metastatic gastric adenocarcinoma or GEJ adenocarcinoma; 7.Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; For patients who have received adjuvant/neoadjuvant chemotherapy in the past, or have received curative radiotherapy and chemotherapy for advanced diseases, if there is a gap of at least 6 months between disease progression or recurrence and the end of the last drug treatment, they are allowed to be included in this study; 8.Good major organ function; 9.Signed informed consent with good compliance, and family agrees to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1.Subjects with known HER2-positive gastric or gastroesophageal junction adenocarcinoma (HER2 3+ or 2+ with positive FISH). If HER2 status is unknown, it must be tested during the screening period. 2.Patients with a history or concurrent other malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ; patients with small gastric stromal tumors and other early-stage tumors that have been treated radically and deemed by the investigator not to affect the patient's life in the short term may be excluded. 3.Participated in another drug clinical trial within four weeks. 4.Known central nervous system (CNS) metastasis or history of CNS metastasis before screening. 5.History of unstable angina; newly diagnosed with angina within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmias (including QTcF >=450 ms for males, >=470 ms for females) requiring long-term antiarrhythmic medication and New York Heart Association Class II or higher heart failure. 6.Urine routine indicates protein >=++ and confirms 24-hour urine protein quantification >1.0 g. 7.Have used immuno-targeted therapy drugs. 8.History of immunodeficiency, other acquired or congenital immunodeficiency diseases, or history of organ transplantation. 9.Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and those requiring corticosteroid therapy. 10.History of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel diseases like ulcerative colitis and Crohn's disease; history of chronic diarrheal diseases like irritable bowel syndrome; history of sarcoidosis or tuberculosis; history of active hepatitis B, C, or HIV infection. 11.Patients with a history of hypersensitivity to human or mouse monoclonal antibodies. 12.Patients with a history of substance abuse involving psychotropic drugs who cannot quit or those with psychiatric disorders. 13.Symptomatic pleural effusion or ascites requiring clinical intervention. 14.Concomitant diseases that, in the judgment of the investigator, pose a significant risk to patient safety or interfere with the patient's ability to complete the study. 15.For female subjects: Must be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method during the study treatment and for 6 months after study treatment ends; a negative serum or urine pregnancy test within 7 days prior to study enrollment is required, and must not be breastfeeding. For male subjects: Must be surgically sterilized, or agree to use a medically approved contraceptive method during the study treatment and for 6 months after study treatment ends.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;QoL;PG-SGA; | — |
Countries
China
Contacts
Public ContactKai Chen
The First Affiliated Hospital of Soochow University
Outcome results
None listed