1 | Diagnosis of distant metastasis by CT/MR/EUS; intraoperative comfirmation of distant metastasis or CY1; R1 or R2 resection. |
2 | Received prior antitumour therapy, including chemotherapy, radiotherapy, targeted or immunotherapy. |
3 | Pregnant or lactating women; women of childbearing age are positive at baseline pregnancy test. |
4 | Other malignancies (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) in the past 5 years. |
5 | Uncontrollable pleural effusion, pericardial effusion or ascites. |
6 | Severe cardiovascular disease, such as symptomatic coronary heart disease, congestive heart failure of grade ≥II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrolment. |
7 | Complicated by upper gastrointestinal obstruction/bleeding or digestive dysfunction or malabsorption syndrome. |
8 | Complicated by severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe kidney injury. |
9 | Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrolment. |
10 | Patients receiving study medications within 4 weeks prior to enrolment (participation in other clinical trials). |
11 | Active autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment, etc). Participants with hypothyroidism requiring hormone replacement therapy and skin conditions that do not require systemic therapy (eg, vitiligo, psoriasis or hair loss) were eligible. |
12 | History of primary immunodeficiency. |
13 | Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding nasal, inhaled or other routes of topical glucocorticoids or physiological doses of systemic corticosteroids (ie, no more than 10 mg/day prednisone or equivalent dose of other glucocorticoids), or use of hormones to prevent contrast allergy. |
14 | Receive live attenuated vaccine within 4 weeks prior to the first dose of study treatment or planned for the duration of the study. |
15 | Patients with known interstitial pulmonary pneumonia and active pulmonary tuberculosis. |
16 | Known history of allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation. |
17 | HIV-positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV-DNA ≥104 copies/mL; hepatitis C: positive for HCV antibodies and HCV-RNA, requiring concurrent antiviral therapy). |
18 | Other factors that may affect participant safety or study adherence as judged by the investigator. Such as serious illness (including mental illness), serious laboratory abnormalities or other family or social factors that require treatment. |