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AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer

RecruitingPhase 2Ages 18 Years - 75 YearsAllHarbin Medical University
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. 2. Imaging examination confirmed unresectable locally advanced or metastatic gastric cancer (GC) or gastroesophageal binding cancer (GEJC), and histopathologically confirmed adenocarcinoma, with at least one measurable tumor lesion (spiral CT or MR scan ≥10mm, gonorrhea The short diameter of sling is ≥15mm, which meets the RECIST 1.1 standard); the lesion that has received radiotherapy is not selected as the target lesion, unless the radiotherapy lesion is the only measurable lesion and is clearly advanced according to imaging judgment, it can be considered as the target lesion; 3. Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months; 4. HER2 is negative. HER2 negative is defined as: IHC 0/1+, or IHC 2+ and FISH/ISH negative (HER2: CEP17 ratio \<2). FISH can be replaced by locally available and accepted ISH methods (such as DISH); 5. The study allowed the inclusion of Subjects with gastric cancer with peritoneal metastasis (imaging results or ascites/abdominal lavage cytology test positive); 6. Expected survival period \> 3 months; 7. ECOG score: 0-1; 8. All acute toxic reactions caused by previous anti-tumor treatment or surgery are relieved to level 0-1 (according to NCI CTCAE version 5.0) or to the level specified in the group/exclusion standard. Except for other toxicicies that researchers such as hair loss, fatigue and hearing damage believe do not pose a safety risk to the subjects; 9. Have good organ function (subsists are not allowed to receive blood transfusion or growth factor support treatment within 7 days before the first administration): 1\) Absolute count of neutrophils ≥1.5×109/L; platelets ≥100×109/L; hemoglobulin ≥90g/L or 5.6mmol/L; 2) Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); ALT and AST ≤2.5×ULN, for liver metastasis subjects, ALT and AST ≤5×ULN; albumin ≥3.0g/dL (30g/L); 3) serum creatinine ≤1.5 ×ULN or calculated serum creatinine clearance ≥50mL/min (Cockcroft-Gault formula calculation). 4\) Normal urine routine, or urine protein \<2+; if urine protein ≥2+, the 24-hour urine protein quantity must be ≤1g; 5) Normal coagulation function, international standardization ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) and activation partial thrombin time (APTT) ≤ 1.5×ULN; 10. Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment. Women of childbearing age and men (who have sex with women of childbearing age) must agree to use effective contraceptives continuously during treatment and 6 months after the last therapeutic dose; 11. Subjects signed the informed consent, and able to follow the planned visit, research treatment, laboratory examination and other experimental procedures. Exclusion Criteria: 1. known as squamous carcinoma, undifferentiated cancer or other tissue types of gastric cancer, or adenocarcinoma mixed with other tissue types of gastric cancer; 2. HER2 positive stomach cancer patients: define IHC 3+, or IHC 2+ and FISH/ISH positive; 3. Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies to ICOS, CD40, CD137, GITR, OX40 targets, etc.) , immune cell therapy and other treatment of any immune mechanism for tumors; 4. In the first 14 days of randomization, there is still uncontrollable pleural hydration and ascites after puncture drainage and other treatments. Imaging shows that a small number of or medium chest and ascites patients can be selected for the study; 5. Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months; 6. There are significant clinical bleeding symptoms or clear bleeding tendencies within 1 month before the first administration, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; 7. There are clinically active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction; 8. Any other malignant tumors have been diagnosed within 5 years before entering the study, except for skin basal or squamous cell carcinoma, superficial bladder cancer, cervical insitus, intraductal cancer and thyroid papilloma cancer that can be treated locally and have been cured with clear medical records; 9. Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease. However, subjects who meet the following requirements and have measurable lesions outside the central nervous system are allowed to enter the group: after treatment, the imaging is stable for at least 4 weeks before the start of the study treatment (if there is no new or expanded brain metastasis), and systemic glucocortic hormone and anticonvulsive drug treatment has been stopped at least 2 weeks; 10. Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia, etc.) are known, and a history of active tuberculosis is known; 11. Subjects with active, known or suspected autoimmune disease. But Subjects who are in a stable state and do not require systematic immunosuppressive treatment are allowed, such as type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not re
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What it tests

  • Cadonilimab
  • Ivonescimab
  • XELOX
  • SOX
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Where

1 site
Harbin Medical University Hospital
Harbin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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