Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

• Status: Active, not recruiting
• Trial end date: 2024-12-11
• Target enrollment: 0
• Participant gender: All

Summary

We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang-Ming Huang, Prof.
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

1. Age from 18 to 75 years

2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

3. cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition

4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.

5. Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)

6. Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.

7. Estimate life is equal or greater than 3 months

8. No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection

9. The main organ function is normal,and meet the following criteria:

• blood routine examination( No blood transfusion within 14 days)

1. HB≥100g/L，

2. WBC≥3.5×109/L

3. ANC≥1.5×109/L，

4. PLT≥100×109/L；

• blood biochemical examination

1. BIL <1.5 Upper Limit Of Normal（ULN），

2. ALT and AST<2.5ULN，GPT≤1.5×ULT；

3. Cr≤1ULN，creatinine clearance>60ml/min（Cockcroft-Gault formula）

10. Written informed consent

Exclusion Criteria:

1. Pregnant and lactating women

2. Suffering from severe mental disorder

3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)

4. History of previous chemotherapy or radiotherapy therapy

5. History of other malignant disease within the past 5 years

6. History of previous neoadjuvant chemotherapy or radiotherapy

7. History of unstable angina or myocardial infarction within the past 6 months

8. History of cerebrovascular accident within the past 6 months

9. History of continuous systematic administration of corticosteroids within 1 month

10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

11. Patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),The history of hematemesis and melena within 2 months,coagulation disorders(INR>1.5、APTT>1.5 ULN).

12. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g)

13. There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction

14. Drug allergy to experimental medicine