Clinical trial · Interventional
Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer
A Single-center Prospective Single-arm Study of the Efficacy of Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer and Its Effect on Tumor Immune Microenvironment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, open, exploratory clinical study to evaluate the efficacy of carrelizumab (PD-1) combined with chemotherapy (SOX/XELOX) as neoadjuvant therapy and to observe the changes of tumor immune microenvironment in patients with locally advanced gastric or gastroesophageal junction cancer (T3-4NXM0).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )
- description
- Camrelizumab + SOX / XELOX
- interventionNames
- Drug: Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )
Primary outcomes (1)
- measure
- Pathological complete response rate (pCR, Becker criteria, TRG 1A)
- timeFrame
- Up to approximately 6 months.
- description
- It was evaluated according to tumor regression grade (Becker standard) : TRG1a had no residual cancer; TRG1b \< 10% residual cancer; TRG2 10%-50% residual cancer; TRG3 \> 50% residual cancer.
Secondary outcomes (2)
- measure
- Major pathological response rate (MPR, TRG1a/ B)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. T3-4NxM0 locally advanced gastric or gastroesophageal junction carcinoma was confirmed by gastroscopic biopsy, CT and pathological examination; 2. No previous systematic treatment for the current disease; 3. Age ≥ 70 years, age ≥18 years, both sexes; 4. ECOG physical status score 0-1; Full organ and bone marrow function: 5. Blood routine: hemoglobin ≥90g/L, neutrophil count ≥1.5×10\^9/L, platelet count ≥75×10\^9/L; Liver function: serum total bilirubin ≤1.5× upper normal value (UNL), aspartate transferase ≤3×UNL, alanine Acid transferase ≤3×UNL; Renal function: serum creatinine ≤1.5×UNL, creatinine clearance rate ≥50ml/min; Coagulation function: INR, APTT and PT ≤1.5×UNL; Serum albumin ≥30g/L; Thyrotropin (TSH) and free thyroxine (fT4) were within the range of normal ±10%. Electrocardiogram showed no obvious abnormality. 6. Not receiving blood transfusion, blood products, or blood cell growth factors such as granulocyte colony-stimulating factor within 2 weeks; 7. Sign an informed consent form before starting the study on a specific screening procedure; 8. The estimated survival time is more than 3 months; 9. Subjects volunteered to join this study, with good compliance, safety and survival follow-up - Exclusion Criteria: Patients with any of the following were excluded from the study: 1. People with allergic disease, history of severe drug allergy, known allergy to macromolecular protein preparations or carrelizumab; 2. Early gastric cancer; 3. Gastric cancer patients with HER2 amplification by pathological gene detection; 4. History of other malignancies (except cured basal cell carcinoma of the skin, cured cervix) with disease-free survival \<5 years Carcinoma in situ and gastrointestinal neoplasms proven to be cured by endoscopic mucosal resection); 5. The presence or history of any active autoimmune disease (including but not limited to: interstitial pneumonia, Uveitis, enteritis, nephritis, hyperthyroidism, hypothyroidism); 6. You are using immunosuppressive agents or hormone therapy (systemic or topical) to achieve immunosuppression, and Continued to use within 2 weeks before enrollment; 7. Severe infection (if intravenous antibiotics, antifungal or antiviral drugs are needed); 8. Congenital or acquired immune deficiency (such as HIV-infected persons), or active hepatitis ((with regular antiviral treatment)
References
Publications (0)
Data not yet available