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

NCT04982939 | Unknown Phase 2

• 1 other identifier: PERSIST
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.

  up to 8 weeks after surgery

Secondary Outcomes (7)

• Tumor down-staging rate

  up to 8 weeks after surgery

• Major pathological response (MPR) rate

  up to 8 weeks after surgery

• 3 years disease-free survival (DFS) rate

  up to 4 years

• 5 years overall survival (OS) rate

  up to 6 years

• Adverse event

  up to 30 days after last treatment administration

Study Arms (2)

Experimental Group-Sintilimab in combination with SOX

EXPERIMENTAL

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.

Drug: Sintilimab; Drug: S-1; Drug: Oxaliplatin

Active Comparator-SOX

ACTIVE COMPARATOR

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

Drug: S-1; Drug: Oxaliplatin

Interventions

Sintilimab DRUG

Sintilimab, 200mg IV d1 Q3W

Also known as: IBI308

Experimental Group-Sintilimab in combination with SOX

S-1 DRUG

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

Active Comparator-SOX; Experimental Group-Sintilimab in combination with SOX

Oxaliplatin DRUG

Oxaliplatin，130mg/m2 d1 Q3W

Active Comparator-SOX; Experimental Group-Sintilimab in combination with SOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Blood routine: absolute neutrophil count (ANC)≥1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin content (HGB)≥9.0 g/dL.
• 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;
• Renal function: Creatinine clearance rate (Ccr) ≥50 mL/min (calculated by Cockcroft/Gault formula):
• Female: Ccr= (140-years old) x weight (kg) x 0.85/(72 x serum creatinine (mg/dL))
• Male: Ccr= (140-years old) x weight (kg) x 1.00/(72 x serum creatinine (mg/dL))
• 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%;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Han Liang, PhD.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Xuewei Ding, PhD.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuewei ding, PhD.

CONTACT

18622220158; xding@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 29, 2021
• Study Start: June 21, 2021
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2024
• Last Updated: August 31, 2021

Record last verified: 2021-07

Locations

CN (1)