Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

NCT ID: NCT03192735

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2024-12-11

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)

Conditions

Apatinib Combined; SOX; Neoadjuvant Therapy; Locally Advanced Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib Combined With SOX

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.

Group Type: EXPERIMENTAL

ApatinibMesylateTablets

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Oxaliplatin for Injection; Gimeracil and Oteracil Porassium Capsules

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang-Ming Huang, Prof.

OTHER

Sponsor Role: lead

Responsible Party

Chang-Ming Huang, Prof.

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Countries

China

References

Lin JX, Xu YC, Lin W, Xue FQ, Ye JX, Zang WD, Cai LS, You J, Xu JH, Cai JC, Tang YH, Xie JW, Li P, Zheng CH, Huang CM. Effectiveness and Safety of Apatinib Plus Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116240. doi: 10.1001/jamanetworkopen.2021.16240.

Reference Type: DERIVED

PMID: 34241629 (View on PubMed)

Other Identifiers

2017YF004-03

Identifier Type: -

Identifier Source: org_study_id