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One-arm, multi-center Simon two-stage design clinical study of albinib mesylate combined with DOS chemotherapy for neoadjuvant treatment of locally advanced gastric cancer (LAGC)

One-arm, multi-center Simon two-stage design clinical study of albinib mesylate combined with DOS chemotherapy for neoadjuvant treatment of locally advanced gastric cancer (LAGC)

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020581
Enrollment
Unknown
Registered
2019-01-09
Start date
2019-01-02
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Gastric cancer

Interventions

Case series:Apatinib+DOS chemotherapy

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old; 2. The ECOG score is less than or equal to 1 point; 3. Pathologically confirmed T3-4aNXM0 locally advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma; 4. The estimated survival period is =12 months; 5. Did not receive pre-treatment against anti-tumor (such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. No previous history of stomach surgery; 7. Tumor lesions can be measured and evaluated. According to RECIST 1.1, patients have at least one target lesion with measurable diameter (CT scan long diameter =10 mm, lymph node lesion CT scan short diameter =15 mm, scan layer thickness is not greater than 5 mm; 8. The main organs function well, that is, the relevant inspection indicators meet the following requirements within 14 days before the start of the study: (1) blood routine examination: hemoglobin > 90 g/L (without blood transfusion within 14 days); neutrophil count > 1.5 × 10^9/L; platelet count > 80 ×10^9/L; (2) biochemical examination: total bilirubin = 1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) = 2 × ULN; if liver metastasis, ALT or AST = 5×ULN; Endogenous creatinine clearance = 50 ml/min (Cockcroft-Gault formula); (3) Assessment of cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) = 50%. 9. Sign the informed consent form; 10. Compliance is good, the family agrees to cooperate with the survival follow-up.

Exclusion criteria

Exclusion criteria: 1. With distant metastasis that cannot be radically removed; 2. Previous or concurrently with other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Have multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) 4. The investigator believes that patients with a clear tendency to gastrointestinal bleeding or / and abnormal blood coagulation (INR > 1.5) have bleeding tendency; 5. Those who have hypertension and are unable to obtain good control by single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); those with a history of unstable angina pectoris; newly diagnosed with angina within 3 months before screening Cardiac infarction occurred within 6 months before screening; arrhythmia (including QTcF: male = 450 ms, female = 470 ms) requires long-term use of antiarrhythmic drugs and New York Heart Association grade = grade II cardiac insufficiency; 6. Severe diseases that are difficult to control (atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction below 50%, renal insufficiency urine protein detection 2+ or more); 7. Other medical treatment (including Chinese medicine) has been carried out before enrollment or it is not guaranteed to follow the research requirements after enrollment; 8. Pregnant or lactating women; 9. Long-term unhealed wounds or incompletely fractured fractures; 10. Imaging shows that the tumor has invaded the important perivascular period or that the patient's tumor has a high probability of invading the important blood vessel during the treatment period and causing fatal bleeding; 11. The investigator believes that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
R0 resection rate;

Secondary

MeasureTime frame
Pathological complete response rate;Objective response rate;Disease free survival;Quality of life score;

Countries

China

Contacts

Public ContactWei Shoujiang

Affiliated Hospital of North Sichuan Medical College

nsmcwsj@163.com+86 13990898462

Outcome results

None listed

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