Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

NCT03192735 | Unknown Phase 2

• 1 other identifier: 2017YF004-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Radical surgical resection rate

  Radical surgical resection rate is defined as the rate of R0 resection

  30 days

Secondary Outcomes (8)

• Pathological response rate

  30 days

• overall response rate

  30 days

• 5-year overall survival rate

  60 months

• 5-year disease free survival rate

  60months

• overall postoperative morbidity rates

  30 days

Study Arms (1)

Apatinib Combined With SOX

EXPERIMENTAL

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.

Drug: ApatinibMesylateTablets

Interventions

ApatinibMesylateTablets 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.

Also known as: Oxaliplatin for Injection, Gimeracil and Oteracil Porassium Capsules

Apatinib Combined With SOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75 years
• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
• cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
• No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
• Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
• Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
• Estimate life is equal or greater than 3 months
• No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection
• The main organ function is normal,and meet the following criteria:
• blood routine examination( No blood transfusion within 14 days)
• HB≥100g/L，
• WBC≥3.5×109/L
• ANC≥1.5×109/L，
• PLT≥100×109/L；
• blood biochemical examination

You may not qualify if:

• Pregnant and lactating women
• Suffering from severe mental disorder
• History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
• History of previous chemotherapy or radiotherapy therapy
• History of other malignant disease within the past 5 years
• History of previous neoadjuvant chemotherapy or radiotherapy
• History of unstable angina or myocardial infarction within the past 6 months
• History of cerebrovascular accident within the past 6 months
• History of continuous systematic administration of corticosteroids within 1 month
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
• 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).
• Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content\>1.0g)
• There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction
• Drug allergy to experimental medicine

Sponsors & Collaborators

• Chang-Ming Huang, Prof.: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

Related Publications (1)

• 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.

  PMID: 34241629 DERIVED

MeSH Terms

Interventions

Oxaliplatin; Injections; gimeracil

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: June 20, 2017
• Study Start: September 1, 2017
• Primary Completion: November 11, 2019
• Study Completion: December 11, 2024
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CN (1)