Peri-operative Sintilimab in Combination With SOX in Locally Advanced Gastric Cancer

NCT ID: NCT04982939

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2024-06-21

Brief Summary

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

Conditions

Gastric Cancer; Perioperative; Sintilimab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group-Sintilimab in combination with SOX

Preoperative treatment: three cycles of sintilimab in combination with SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX, Sintilimab up to one year.

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

Sintilimab, 200mg IV d1 Q3W

S-1

Intervention Type: DRUG

S-1, 40-60mg BID d1-14 Q3W

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin，130mg/m2 d1 Q3W

Active Comparator-SOX

Preoperative treatment: three cycles of SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX.

Group Type: ACTIVE_COMPARATOR

S-1

Intervention Type: DRUG

S-1, 40-60mg BID d1-14 Q3W

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin，130mg/m2 d1 Q3W

Interventions

Sintilimab

Sintilimab, 200mg IV d1 Q3W

Intervention Type: DRUG

S-1

S-1, 40-60mg BID d1-14 Q3W

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin，130mg/m2 d1 Q3W

Intervention Type: DRUG

Other Intervention Names

IBI308

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Han Liang, PhD.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Xuewei Ding, PhD.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuewei ding, PhD.

Role: CONTACT

Phone: 18622220158

Email: xding@tmu.edu.cn

Facility Contacts

Xuewei Ding, PhD.

Role: primary

Other Identifiers

PERSIST

Identifier Type: -

Identifier Source: org_study_id