Apatinib Plus XELOX as Neoadjuvant Therapy in Locally Advanced Gastric Cancer

Phase 2

• Conditions: Chemotherapy Effect; Gastric Cancer; Chemotherapeutic Toxicity
• Interventions: Drug: Apatinib plus XELOX

• Registration Number: NCT03229096
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer PatientsWith lymph node metastasis

Detailed Description

This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial evaluating the efficacy and safety of Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer Patients With lymph node metastasis

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-07-22
• Study First Submitted QC: 2017-07-22
• Study First Posted: 2017-07-25
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-28
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Adult patients, age ≥18 years.
2. Karnofsky score 70%.
3. Histologically confirmed adenocarcinoma of gastric cancer with Lauren classification Clinically diagnosed stage T2-T4aN+M0 according to CT/MRI scan.
4. At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1), that is one or more perigastric lymph note were greater than or equal to 1.5cm in diameter.
5. Laparoscopic exploration confirms no peritoneal metastasis and negative peritoneal lavage.
6. Physical condition and adequate organ function to ensure the success of abdominal surgery.
7. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL. Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.Adequate renal function: Serum creatinine ≤ 1 x ULN, and serum albumin≥30g/L.
8. Life expectancy of more than 5 years without serious concomitant diseases.
9. Written (signed) informed consent.
10. Able to comply with study and follow-up procedures.
11. Consent to provide tissue sample.

Exclusion Criteria

1. Pregnant or lactating women.
2. pregnancy tests before entering the group (in serum) of the childbearing age women were positive, or no pregnancy tests.
3. patients with distant metastases or local unresectable factors.
4. tumor stage considered as cT1 by imaging or ultrasound gastroscopy.
5. Patients who received prior anti-tumor therapy including cytotoxic chemotherapy, radiotherapy, hormonal therapy and immunotherapy.
6. History of other malignancies within the last 5 years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix.
7. History of significant neurological or mental disorder, including seizures or dementia, which may interfere compliance and sign of consent inform.
8. Unstable, persistent cardiac disease despite medicinal treatment; myocardial infarction within 12 months before the start of the trial.
9. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management.
10. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug absorption.
11. Patients who experienced GI bleeding within two weeks, or with high risk of bleeding.
12. Patients with symptomatic peripheral neuropathy NCI CTC version> 1.0 grade, except only the deficiency of Deep tendon reflex.
13. Organ transplant patient need immunosuppression treatment.
14. Active or uncontrolled severe infection or other severe and /or uncontrolled diseases
15. Patients with moderate or severe chronic kidney disease estimated glomerular filtration rate≤50 ml/min or serum creatinine ≥the upper limit of normal(ULN),
16. deficiency of dihydropyrimidine dehydrogenase (DPD)
17. Allergy to the drugs in this protocol
18. Less than 4 weeks from the last clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib plus XELOX	Apatinib plus XELOX	Patients will be given the perioperative chemotherapy of Apatinib plus XELOX once recruited

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	3 months	Both CR and PR according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

Secondary Outcome Measures

Name	Time	Method
Pathological response rate (pRR)	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.
3-year disease free survival rate	3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	30 days	The safety of the the perioperative treatment, percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments
3-year overall survival rate	3 years

Trial Locations

Locations (1)

ZhongShan hospital FuDan university; 🇨🇳 Shanghai, Shanghai, China