临床试验雷达

Primary platinum-refractory is defined as disease that has not been relieved (CR) during first-line platinum-containing chemotherapy or within 3 months after the last dose Or PR) or imaging progression;

History of active central nervous system metastasis, leptomeningeal metastasis or carcinomatous meningitis with stable evaluation by the investigator Excluding brain parenchyma metastases, stability is defined by the following criteria: no related symptoms and at least one recent imaging showing a stable state; or stable for more than 1 month without symptoms after treatment, and no need to use glucocorticoids or anticonvulsants for at least 2 weeks;

Received any investigational drug within 28 days prior to randomization;

Five half-lives (the shorter time) within 28 days prior to randomization of other antitumor therapy or antitumor drugs Equivalent but at least 14 days); Received Chinese herbal medicine with a clear anti-tumor indication within 14 days prior to randomization;

Received local palliative treatment within 14 days prior to randomization;

Had major surgery (such as abdominal or thoracic surgery; not including diagnostic surgery) within 28 days prior to randomization Small operations such as puncture or infusion device implantation or biliary stent implantation), or major surgery is expected to be required during the study treat;

There are obvious clinical manifestations of gastrointestinal abnormalities, including but not limited to: intestinal obstruction existed or existed within 3 months before administration Symptoms and signs of intestinal obstruction, but screening can be performed if surgery has been performed and the obstruction is completely relieved (if previously received Patients who have undergone gastrointestinal stent implantation and whose stents remain in place at the screening stage are not eligible for enrollment); within 3 months before dosing, there has been a gastrointestinal perforation, gastrostomy, or intra-abdominal abscess; within 3 months before dosing, there has been CTCAE grade ≥3 gastrointestinal bleeding, or within 1 month before randomization, there has been gastrointestinal bleeding (including melena, hematochezia, etc., if confirmed as hemorrhoidal bleeding or only positive occult blood in stool, they can be enrolled);

Uncontrolled and recurrent (recurrent within 2 weeks of intervention) moderate to large pleural effusions such as the chest Subjects with water, pericardial effusion, ascites and cachexia;

Other malignant tumors were combined within the previous 5 years, excluding curable squamous cell carcinoma of skin, basal cell carcinoma and non-basal infiltration Bladder cancer with lubrication, in situ prostate/cervical/breast cancer;

Past or current interstitial pneumonia/pulmonary disease requiring systemic glucocorticoid therapy, or imaging during screening The examination could not rule out suspected interstitial pneumonia/pulmonary disease;

The presence of uncontrolled comorbidities, including but not limited to:

• Active HBV or HCV infection. HBsAg (+), HBV-DNA <2500 copies/mL or 500 Enrollment is allowed at IU/mL; enrollment is allowed if HCV-Ab (+) and HCV-RNA test is negative;
• HIV infection;
• Known active tuberculosis;
• Active syphilis;
• There is an active or uncontrolled infection within 2 weeks prior to the randomization, and systemic antimicrobial therapy is required;
• Uncontrolled hypertension (systolic blood pressure ≥180mmHg, diastolic blood pressure> 100 mmHg) and symptomatic heart failure Full (NYHA II-IV), refractory hypokalemia, long QT syndrome, moderate to severe pulmonary hypertension;
• Severe arrhythmias of important medical significance, including but not limited to ventricular tachycardia, ventricular fibrillation, and apex torsion A history of transition tachycardia, complete left or right bundle branch block, second or third degree cardiac conduction block;
• Unstable angina or myocardial infarction within 6 months;
• New diagnosis of a treatable thromboembolic event within 6 months (control of stable lower extremity deep vein thrombosis or infusion Thrombosis subjects such as liquid ports are allowed to be included)

The toxicity of previous anti-tumor therapy has not been restored to CTCAE≤1 grade (NCI-CTCAE v5.0); Note: Participants with stable grade CTCAE 2 toxicity related to prior anti-tumor therapy can be enrolled (defined as stable toxicity severity within 3 months before dosing, with no CTCAE grade greater than 2), such as neurotoxicity, hair loss, skin pigmentation, fatigue caused by chemotherapy, and endocrine toxicity from prior immunotherapy (e.g., thyroid dysfunction, diabetes, hyperglycemia, adrenal insufficiency);

Previous history of allogeneic bone marrow or organ transplantation;

History of previous allergic reactions to antibody drugs and hypersensitivity reactions;

Other researchers believe that conditions that may affect the safety or compliance of treatment with the study drug, including but not limited to mental illness Class diseases, alcoholism or drug abuse, etc.