Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Neoadjuvant Therapy Clinical Trial

Official title:

Apatinib Combined With Oxaliplatin and Gimeracil and Oteracil Porassium Capsules Neoadjuvant Therapy for Locally Advanced Gastric Cance: A Multicentre, One-armed, Clinical Pilot Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03192735
• Other study ID #: 2017YF004-03
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 1, 2017
• Est. completion date: December 11, 2024

Study information

• Verified date: February 2020
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 11, 2024
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apatinib Combined
• Locally Advanced Gastric Cancer
• Neoadjuvant Therapy
• SOX
• Stomach Neoplasms

Intervention

Drug:
• ApatinibMesylateTablets
Subject will be given ApatinibMesylateTablets 500mg/per day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 /per 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.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Chang-Ming Huang, Prof.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radical surgical resection rate	Radical surgical resection rate is defined as the rate of R0 resection	30 days
Secondary	Pathological response rate	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.	30 days
Secondary	overall response rate	according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1	30 days
Secondary	5-year overall survival rate		60 months
Secondary	5-year disease free survival rate		60months
Secondary	overall postoperative morbidity rates	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.	30 days
Secondary	Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
Secondary	30 days mortality rates	Defined as the event observed within 30 days after surgery.	30 days
Secondary	adverse event	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.	60 months