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Clinical study of the efficacy and safety of Sintilimab combined with Oxaliplatin/S-1 (SOX) and radiotherapy in neoadjuvant therapy for locally advanced gastroesophageal junction adenocarcinoma

Clinical study of the efficacy and safety of Sintilimab combined with Oxaliplatin/S-1 (SOX) and radiotherapy in neoadjuvant therapy for locally advanced gastroesophageal junction adenocarcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046154
Enrollment
Unknown
Registered
2021-05-05
Start date
2021-05-05
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal junction tumor

Interventions

experimental group:PD-1 inhibitor + SOX chemotharapy + radiotherapy

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign written informed consent prior to the implementation of any test-related procedures; 2. Male or female, aged 18 to 70 years; 3. Histologically confirmed gastroesophageal junction adenocarcinoma was diagnosed as CT3-4ANXM0 (AJCC 8th Edition) according to endoscopic ultrasonography, esophageal barium meal, or enhanced CT/MRI scan (CTNM). Siewert classification was II- normal type. 4. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there should be at least one radiologically measurable lesion; 5. No previous surgical treatment or anti-tumor chemoradiotherapy/immunotherapy; 6. Patients who agree to undergo radical surgical treatment; 7. Patients with no obvious surgical contraindication judged by the surgeon to be able to perform radical resection initially; 8. ECOG score 0-1; 9. Expected survival time > 6 months.

Exclusion criteria

Exclusion criteria: 1. Other malignant diseases other than gastric cancer diagnosed within 5 years prior to the first administration (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Patients with preoperative endoscopic biopsy showing positive HER-2 (immunohistochemical +++, or positive FISH test); 3. Active bleeding signs of the lesion are known under endoscopy; 4. Is currently participating in an interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 5. Have received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2; 6. Receive Chinese patent drugs with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration.

Design outcomes

Primary

MeasureTime frame
Pathologic complete response;

Countries

China

Contacts

Public ContactLiu hongli

Cancer Center of Union Medical College Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology

hongli_liu@hust.edu.cn+86 13995680822

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026