Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02)
Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02)
This study is a prospective, single arm, multi-center phase II clinical trial. The primary
 study objective is to evaluate the safety of tegafur gimeracil oteracil potassium capsule
 plus oxaliplatin and Camrelizumab as adjuvant therapy in stage III gastric cancer, including
 the incidences and types of adverse events. The secondary study objective is to observe and
 evaluate the disease-free survival (DFS), overall survival (OS) and treatment completion
 rate.
1. Study population: participants with stage III gastric cancer confirmed by postoperative
 pathology according to American Joint Committee on Cancer (AJCC) / Union for
 International Cancer Control (UICC) 8th Tumor Node Metastasis (TNM) staging
 classification.

 2. Sample size: single arm design was used in this study and 52 participants were estimated
 to be enrolled.

 3. Research content: In this study, within 4-6 weeks after the completion of the operation,
 the participants were selected and qualified for this study, and were scheduled to
 receive 200mg camrelizumab once intravenous infusion on the first day (q3w), then
 130mg/m^2 oxaliplatin on the first day (q3w), and tegafur gimeracil oteracil potassium
 capsule was taken as follow: surface area is less than 1.25, 80mg per day, twice a day;
 ≥1.25 ~ <1.5, 100mg per day, twice a day; ≥1.5, 120mg per day, twice a day, and oral
 administration for 1-14 days every 3 weeks. Three weeks as a course of treatment, a
 total of 8 courses, after treatment, safety visit and survival follow-up will be carried
 out. A total of 3 years follow-up time is scheduled since the first medication, and the
 frequency is once every 3-6 months within 2 years, and once every 6-12 months for the
 third year.

 4. Adverse events (AEs) management: To minimize the risk of AEs, the investigators will
 monitor carefully to determine whether or not they are within the expected range. The
 degree of AEs is evaluated according to The National Cancer Institute Common Terminology
 Criteria for Adverse Events (NCI-CTCAE v 4.0). Investigators will also conduct a
 thorough examination and adopt an appropriate system to take any necessary measures to
 deal with AEs.
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.