A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma

NCT07492615 | Recruiting Phase 2

• 1 other identifier: 2511333-9
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with SOX or SOX alone as adjuvant therapy.

Conditions

Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Keywords

Gastrci cancer or Gastroesophageal Junction Adenocarcinoma; Adjuvent Therapy

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival (3yr-DFS)

  DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.

  Up to 3 years after surgery

Secondary Outcomes (3)

• disease-free survival (DFS)

  Up to 5 years after surgery

• Overall Survival(OS)

  Up to 7 years after enrollment

• Adverse events(all grades）

  From the first dose of system therapy up to 90 days after the last dose

Study Arms (2)

Sintilimab and SOX

EXPERIMENTAL

Drug: Sintilimab; Drug: S-1 & Oxaliplatin

SOX

ACTIVE COMPARATOR

Drug: S-1 & Oxaliplatin

Interventions

Sintilimab DRUG

200 mg, administered intravenously, d1, every 3 weeks

Sintilimab and SOX

S-1 & Oxaliplatin DRUG

S-1:Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks. Oxaliplatin: 130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks.

SOX; Sintilimab and SOX

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent.
• Male or female, age ≥18 years.
• Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
• Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB.
• Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic sequencing.
• Underwent D2 or more extensive radical resection and achieved R0 resection.
• Able to swallow tablets normally.
• ECOG performance status 0-1.
• Life expectancy \>6 months.
• Adequate organ function, subjects must meet the following laboratory criteria:
• Absolute neutrophil count (ANC) ≥1.5×10\^9/L without granulocyte colony-stimulating factor within the past 14 days.
• Platelets ≥100×10\^9/L without transfusion within the past 14 days.
• Hemoglobin \>9 g/dL without transfusion or erythropoietin use within the past 14 days.
• Total bilirubin ≤1.5×ULN; if total bilirubin \>1.5×ULN but direct bilirubin ≤ULN, enrollment is also permitted.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN.

You may not qualify if:

• Cancers involving the EGJ with the tumor center located in the proximal stomach ≤2 cm from the EGJ.
• Diagnosis of any other malignant disease other than gastric cancer within 5 years prior to first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ).
• Currently participating in interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to first dose.
• Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).
• Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferons, interleukins, except for local use to control pleural effusion) within 2 weeks prior to first dose.
• Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.
• Receiving systemic corticosteroid therapy (excluding nasal spray, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to first dose.
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• Known allergy to any drug used in this study.
• Has not adequately recovered from toxicities and/or complications caused by any prior intervention prior to starting treatment (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or alopecia).
• Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
• Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number above the upper limit of normal of the testing laboratory at the study site). Subjects meeting the following criteria may also be enrolled:
• HBV viral load \<1000 copies/ml (200 IU/ml) prior to first dose, subjects should receive anti-HBV therapy during the entire study chemotherapy treatment to prevent reactivation.
• For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed.
• Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200230, 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

• Xiaowen Liu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Liu

CONTACT

18017317145; liuxw1129@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastric Surgery

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 25, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): February 20, 2029
• Study Completion (Estimated): February 20, 2033
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)