Clinical trial NCT04982939: Peri-operative Sintilimab in Combination With SOX in Locally Advanced Gastric Cancer
Official title: Efficacy and Safety of Peri-operative Sintilimab in Combination With SOX in Resectable Locally Advanced Gastric Cancer: a Multiple-center Open-label Randomized Phase II Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Perioperative
Sintilimab
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of peri-operative sintilimab in combination with SOX in resectable locally advanced gastric or gastroesophageal junction adenocarcinoma


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years old ≤ age ≤ 75 years old
* ECOG PS score 0-1
* Treatment naive patients diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma by histopathology
* No known HER2-positive status;
* Clinical stage Ⅱ, Ⅲ (T1-4a N+ M0, T3-4a N0 M0, AJCC 8th)
* The research center and the surgeon can complete D2 radical gastrectomy
* Physical condition and organ function allow for larger abdominal surgery
* Sufficient organ and bone marrow function, which is defined as follows:

  1. Blood routine: absolute neutrophil count (ANC)≥1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin content (HGB)≥9.0 g/dL.
  2. Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ×ULN;
  3. Renal function: Creatinine clearance rate (Ccr) ≥50 mL/min (calculated by Cockcroft/Gault formula):

     1. Female: Ccr= (140-years old) x weight (kg) x 0.85/(72 x serum creatinine (mg/dL))
     2. Male: Ccr= (140-years old) x weight (kg) x 1.00/(72 x serum creatinine (mg/dL))
  4. The coagulation function is adequate, defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the proposed range of anticoagulation drugs
* LVEF≥50%;
* Agree and be able to comply with the plan during the research period;
* Provide written informed consent before entering the study screening, and the patient has understood that participants can withdraw from the study at any time during the study without any loss;

Exclusion Criteria:

* Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome;
* Complicated with severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe renal injury;
* Received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.;
* Suffered from other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer);
* Uncontrollable pleural effusion, pericardial effusion or ascites;
* Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction;
* Allergic reactions to the drugs used in this study;
* Use steroids or other systemic immunosuppressive therapies 14 days before enrollment;
* Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials);
* Active autoimmune diseases;
* History of primary immunodeficiency;
* Have used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal spray, inhaled or other local glucocorticoids or physiological doses of systemic glucocorticoids (that is, no more than 10 mg/day Pred nisone or other glucocorticoids in equivalent doses), or use hormones to prevent allergy to contrast agents;
* Within 4 weeks before the first dose of study treatment or plan to receive live attenuated vaccine during the study period;
* Known to have active tuberculosis;
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
* HIV antibody positive, active hepatitis B or C (HBV, HCV);
* Pregnant or lactating women

Primary outcomes:
measure: Pathological complete response (pCR) rate
timeFrame: up to 8 weeks after surgery
Secondary outcomes:
measure: Tumor down-staging rate
timeFrame: up to 8 weeks after surgery
measure: Major pathological response (MPR) rate
timeFrame: up to 8 weeks after surgery
measure: 3 years disease-free survival (DFS) rate
timeFrame: up to 4 years
measure: 5 years overall survival (OS) rate
timeFrame: up to 6 years
measure: Adverse event
timeFrame: up to 30 days after last treatment administration
measure: Overall response rate ( ORR)
timeFrame: up to 30 days after last preoperative treatment administration
measure: Disease Control Rate (DCR)
timeFrame: up to 30 days after last preoperative treatment administration
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Han Liang, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Xuewei Ding, PhD.
role: PRINCIPAL_INVESTIGATOR
References: