Clinical trial · Interventional
Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma
Cisplatin and S-1 With or Without Nimotuzumab for Patients With Previously Untreated Advanced Gastric Adenocarcinoma: a Single-center, Randomised, Open-label, Parallel-group, Controlled Phase 2 Clinical Trial
- 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)
In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group. The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.
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 |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| nimotuzumab | Drug | Nimotuzumab | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NCS
- description
- nimotuzumab plus cisplatin and S-1
- interventionNames
- Drug: nimotuzumab
- Drug: cisplatin
- Drug: S-1
- type
- ACTIVE_COMPARATOR
- label
- CS
- description
- cisplatin and S-1
- interventionNames
- Drug: cisplatin
- Drug: S-1
Primary outcomes (1)
- measure
- Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. provision of written informed consent; 2. male or female; and aged ≥ 18 years; 3. Histologically verified, untreated, metastatic or locally advanced inoperable adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal junction; 4. At least one radiographically documented measurable lesion according to Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST1.1) Criteria; 5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and a life expectancy ≥ 3months; 6. No previous palliative chemotherapy; 7. Adequate function of vital organs: white blood cells (WBC) ≥ 4.0×109/L, neutrophils (ANA) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90g/L (blood transfusion is permitted if necessary), serum bilirubin ≤ 1 times the upper normal limit (UNL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the UNL, alkaline phosphatase (AKP) ≤ 5 times the UNL, creatinine (Cr) ≤ 1 times the UNL, normal electrocardiography (ECG). Exclusion Criteria: 1. pregnant or lactating patients, or reproductive women without effective contraception; 2. Patients with only non-measurable disease: small lesions (longest diameter \< 10mm or pathological lymph nodes with ≥ 10 to \< 15mm short axis), Bone lesions, leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung; abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques. 3. Symptomatic of brain metastasis; 4. Patients with clinically severe comorbidity including diabetes mellitus, hypertension, heart disease, or chronic active hepatitis (HBV carrier can be enrolled if circumstance permits ); 5. No previous radiotherapy for measurable lesions.
References
Publications (0)
Data not yet available