Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Phase 2

Active, not recruiting

• Conditions: SOX; Neoadjuvant Therapy; Apatinib Combined; Locally Advanced Gastric Cancer
• Interventions: Drug: ApatinibMesylateTablets

• Registration Number: NCT03192735
• Lead Sponsor: Chang-Ming Huang, Prof.

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-18
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Study Start: 2017-09-01
• Primary Completion: 2019-11-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Study Completion: 2024-12-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib Combined With SOX	ApatinibMesylateTablets	In this group,subject will be given ApatinibMesylateTablets 500mg one time a day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 one time a day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.

Primary Outcome Measures

Name	Time	Method
Radical surgical resection rate	30 days	Radical surgical resection rate is defined as the rate of R0 resection

Secondary Outcome Measures

Name	Time	Method
Pathological response rate	30 days	Briefly, pathCR (Pathological complete rate) was defined as an absence of carcinoma cells in the primary site, and pathologic partial response (pathPR) was defined as less than 10% residual carcinoma cells in the specimen.
5-year disease free survival rate	60months
overall postoperative morbidity rates	30 days	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
overall response rate	30 days	according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
30 days mortality rates	30 days	Defined as the event observed within 30 days after surgery.
5-year overall survival rate	60 months
Duration of postoperative hospital stay	30 days	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
adverse event	60 months	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China