peritoneal metastatic carcinoma
Conditions
Interventions
Group A:Lukang saltuzumab + bevacizumab
Group B:Lukang saltuzumab
Sponsors
Beijing luhe hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily agree to participate in this study and sign the informed consent form. 2. Patients with clinically confirmed secondary peritoneal metastasis of gastric cancer or colorectal cancer who have progressed after receiving >=2 lines of standard treatment. 3. Collect the patient's tissue samples for TROP2 expression detection, and determine as high TROP2 expression (H-score >=100 or IHC calculation of the proportion of tumor cells with 2+ and 3+, requiring >75%). 4. Age>=18 years and =1.5×10^9/L; (2) Platelet count >= 100×10^9/L; (3) Hemoglobin >= 9.0g/dL. 11. Adequate liver function: (Based on the normal value of the clinical trial center) (1) Total bilirubin (TBIL) = 50mL/min (using the Cockcroft-Gault formula) 13. Adequate coagulation function: Activated partial thromboplastin time (APTT) = 50% as detected by echocardiography within 28 days before enrollment; (2) New York Heart Association (NYHA) classification < 3.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors within 5 years before drug administration (except for those cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and cervical carcinoma in situ, etc.) 2. Patients who have received chemotherapy within 3 weeks before the first use of the study drug, or radiotherapy, radioactive particle implantation (except for bone radioactive particle implantation for pain relief and local radiotherapy within 2 weeks before the first use of the study drug), or any drug treatment targeting topoisomerase I, including antibody-drug conjugate (ADC) treatment within 4 weeks before the first administration. 3. Patients with known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, active or untreated central nervous system (CNS) metastasis. For patients with previously treated brain metastases, if they are clinically stable for at least 4 weeks before medication and do not require glucocorticoids or anticonvulsants for at least 14 days, they may be eligible for inclusion. 4. Patients with adverse reactions from previous anti-tumor treatment that have not recovered to CTCAE 5.0 grade = 10 mmol/L for two consecutive times); (2) Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); (3) Presence of symptomatic or untreated pleural effusion, pericardial effusion or ascites (more than once a week) 6. Patients with a history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, currently having ILD or non-infectious pneumonia, or having suspicious ILD or non-infectious pneumonia that cannot be excluded by imaging examination at screening 7. Patients with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding 8. Patients with active autoimmune diseases requiring systemic treatment within the past two years, systemic treatment including disease-modifying drugs, immunosuppressants, systemic corticosteroid administration (> 10 mg/day prednisone or equivalent drugs), etc. Hormone replacement therapy, such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered systemic treatment; patients who have received systemic corticosteroid treatment (> 10 mg/day prednisone) or other immunosuppressive drugs within 2 weeks before administration 9. Known active pulmonary tuberculosis. Patients suspected of having active pulmonary tuberculosis need to undergo clinical examination to rule it out 10. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 11. Active hepatitis B [positive hepatitis B surface antigen (HBsAg), HBV-DNA testing is required; HBV-DNA >= 500 IU/mL or higher than the lower limit of detection, whichever is higher] or hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of detection). Note: For HBsAg-positive patients, antiviral treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Progression Free Survival;Adverse Event; | — |
Countries
China
Contacts
Public ContactDong Yan
Beijing luhe hospital Affiliated to Capital Medical University, Beijing, China
Outcome results
None listed