Clinical Trial Radar

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• Pregnant or lactating patients;

• Patients who have received prior antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy;

• Patients with other malignancies within the past 5 years (excluding basal cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer);

• Uncontrolled pleural effusion, pericardial effusion, or ascites;

• Clinically determined to be inoperable or with distant metastasis;

• Severe cardiovascular disease within 12 months prior to enrollment, such as symptomatic coronary artery disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, myocardial infarction;

• Concurrent upper gastrointestinal obstruction/bleeding, digestive dysfunction, or malabsorption syndrome;

• History of gastrointestinal perforation within 6 months prior to enrollment;

• Concurrent severe uncontrolled infections or other severe uncontrolled comorbidities, moderate or severe renal impairment;

• Uncontrolled cardiac clinical symptoms or conditions, such as:

  1. NYHA Class II or higher heart failure (see Appendix 5) or echocardiography showing LVEF <50%;
  2. Unstable angina;
  3. Myocardial infarction within 1 year prior to study treatment initiation;
  4. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc > 450 ms (males); QTc > 470 ms (females) (QTc interval calculated using Fridericia's formula; if QTc is abnormal, measure three consecutive times at 2-minute intervals and take the average);

• History of allergic reactions to drugs used in this study;

• Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding intranasal, inhaled, or other locally administered corticosteroids, or physiologically dosed systemic corticosteroids (i.e., not exceeding 10 mg/day of prednisone or equivalent doses of other corticosteroids), or corticosteroids used for contrast medium allergy prophylaxis;

• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;

• Current interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring corticosteroid therapy, or other pulmonary conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on screening chest computed tomography (CT) or severe pulmonary impairment. Radiation pneumonitis in the radiation field is permitted. Active tuberculosis.

• Active autoimmune disease or history of autoimmune disease with potential for recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \[subjects controllable only with hormone replacement therapy may be included\]); Subjects with skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia), controlled type 1 diabetes managed with insulin, or childhood asthma in complete remission requiring no adult intervention may be included; asthma patients requiring bronchodilator medical intervention are excluded;

• Use of immunosuppressive agents or systemic corticosteroids for immunosuppression within 14 days prior to study treatment initiation (dose > 10 mg/day prednisone or equivalent);

• Severe infection within 4 weeks prior to study treatment initiation, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; therapeutic antibiotic administration (oral or intravenous) within 2 weeks prior to study treatment initiation (patients receiving prophylactic antibiotics, e.g., for urinary tract infection prevention or chronic obstructive pulmonary disease exacerbation prevention, are eligible);

• Patients with congenital or acquired immunodeficiency (e.g., HIV infection);

• Use of immunosuppressive drugs within 4 weeks prior to first dose;

• Administration of live attenuated vaccines within 4 weeks prior to first dose or planned administration of live attenuated vaccines during the study period;

• Previous treatment with other anti-PD-1 antibodies or other PD-1/PD-L1-targeted immunotherapies;

• Palliative radiotherapy to non-target lesions for symptom control is permitted, provided it was completed at least 2 weeks prior to study treatment initiation and radiotherapy-related adverse events have not recovered to ≤CTCAE Grade 1;

• Receipt of other investigational drug treatment within 28 days prior to study treatment initiation; The investigator determined that the patient has other factors that may affect study outcomes or necessitate premature termination of this study, such as alcohol abuse, substance misuse, other serious medical conditions (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or accompanying family or social factors that could compromise patient safety.