| Eligibility |
Inclusion Criteria:
1. Voluntary participation in the clinical study; fully understands and is informed of
the study and has signed the Informed Consent Form (ICF).
2. The gender is not limited. Age: = 18 years and = 75 years old.
3. Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology.
4. Without evidence of distant metastatic disease before operation by imaging.
5. Received D2 or D2+ radical gastrectomy by open surgery (R0 resection).
6. Stage III gastric cancer confirmed by postoperative pathology (AJCC/UICC 8th TNM
staging classification).
7. Participants with a performance status of 0 ~ 1 on the Eastern Cooperative Oncology
Group (ECOG) within 7 days before the first dose of study treatment.
8. Life expectancy = 6 months.
9. The functions of the vital organs meet requirements as follow (within 14 days before
the first dose of study treatment, participant has not received treatment of blood
transfusion, albumin, recombinant human thrombopoietin or granulocyte stimulating
factor):
A. Hematological function:
- White blood cell count (WBC): 3.5 × 10 ^ 9 / L ~12.0 × 10 ^ 9 / L;
- Absolute neutrophil count (ANC) = 1.5 × 10 ^ 9 / L;
- Platelet count (PLT) = 100 × 10 ^ 9 / L;
- Hemoglobin (Hb) = 90 g / L.
B. Hepatic function:
- Total bilirubin (TBIL) = 1.5 × ULN (upper limit of normal);
- Aspartate aminotransferase (AST) = 2.5 × ULN;
- Alanine aminotransferase (ALT) = 2.5 × ULN;
- Albumin (ALB) = 30 g / L.
C. Renal function:
- Creatinine (Cr) = 1.5 × ULN, or creatinine clearance = 60 ml / min for those with
creatinine level > 1.5 × ULN.
D. Coagulation function:
- International normalized ratio (INR) = 1.5;
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) = 1.5 ×
ULN.
10. Female of childbearing age must meet requirements: urine pregnancy test must be
negative within 7 days before the first dose of study treatment, and she must agree to
use adequate contraception methods or keep abstinence (starting with the ICF is signed
through 120 days after the last dose of camrelizumab, or 180 days after the last dose
of chemotherapy, whichever is longer, and should not be breastfeeding. For the male
participants must meet requirements: agree to use adequate contraception methods or
keep abstinence (starting with the ICF is signed through 120 days after the last dose
of camrelizumab, or 180 days after the last dose of chemotherapy, whichever is
longer).
Exclusion Criteria:
1. Received previous chemotherapy, radiotherapy, targeted therapy or immunotherapy.
2. Previous or concurrent have other active malignant tumors (except for basal cell or
squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or
cervical cancer or breast cancer in situ that has undergone curative therapy).
3. Existence of unrecovered complications after radical gastrectomy before the first dose
of study treatment (including but not limited to: infection, gastrointestinal
bleeding/ obstruction, anastomotic fistula, pancreatic fistula and anastomotic
stenosis).
4. Myocardial infarction within 6 months before the first dose of study treatment,
uncontrolled angina, arrhythmia which need medical intervention (including but not
limited to cardiac pacemaker), congestive heart failure (New York Heart Association
(NYHA) class III or IV), echocardiogram shows left ventricular ejection fraction
(LVEF) < 50%.
5. Existence of chronic diarrhea (watery diarrhea: = 5 times per day).
6. Participants with active infection within 14 days before the first dose of study
treatment which need medical intervention.
7. Participants with active tuberculosis.
8. Previous or concurrent diagnosed with interstitial lung disease by imaging or
symptoms.
9. Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody,
Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.
10. Females who are pregnant or breastfeeding or expecting to conceive during the study
period.
11. Participants who need long-term systemic steroid therapy (> 10 mg/d prednisone
equivalent) or any other form of immunosuppressive therapy within 14 days before the
first dose of study treatment or during the study period.
12. Concurrent or previous have severe allergic reaction to any antibody-based drugs.
13. Existence of any concurrent autoimmune disease, excepting participants with diabetes
mellitus type I, hypothyroidism requiring only hormone replacement therapy and skin
diseases without systemic treatment (such as vitiligo, psoriasis or alopecia).
14. Receive live vaccines within 28 days before the first dose of study treatment or
during the study period, excepting inactivated viral vaccines for seasonal influenza.
15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem
cell transplantation.
16. Existence of systemic disease that is difficult to control despite treatment with
several agents, for example, diabetes mellitus, hypertension, etc.
17. Existence of other serious physical or mental diseases or serious laboratory
abnormalities that may increase the risk of participating in the study. Participants
who were judged unsuitable as subjects of this trial by investigator.
|
