Apatinib Plus XELOX as Neoadjuvant Therapy in Locally Advanced Gastric Cancer

NCT03229096 | Unknown Phase 2

• 1 other identifier: ZSGC-002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chemotherapy Effect; Chemotherapeutic Toxicity; Gastric Cancer

Keywords

gastric cancer; neoadjuvant chemotherapy; apatinib

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Both CR and PR according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

  3 months

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  30 days

• Pathological response rate (pRR)

  30 days

• 3-year disease free survival rate

  3 years

• 3-year overall survival rate

  3 years

Study Arms (1)

Apatinib plus XELOX

EXPERIMENTAL

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

Drug: Apatinib plus XELOX

Interventions

Apatinib plus XELOX DRUG

three weeks is one cycle, 4 cycles followed by radical gastrectomy. Apatinib: 250 mg, p.o., qd, every 3 weeks for the first two cycles. if no level 3 or severer AEs happened, change apatinib to 500mg, p.o.,qd, otherwise keep 250mg in the third cycle. no apatinib in the fourth cycle. Capecitabine: 1000mg/m2, p.o., bid, D1-14, every 3 weeks (treatment for 2 weeks and rest 1 week). Oxaliplatin: 130mg/m2, i.v. over 2h, D1, every 3 weeks.

Apatinib plus XELOX

Eligibility Criteria

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

You may qualify if:

• Adult patients, age ≥18 years.
• Karnofsky score 70%.
• Histologically confirmed adenocarcinoma of gastric cancer with Lauren classification Clinically diagnosed stage T2-T4aN+M0 according to CT/MRI scan.
• 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.
• Laparoscopic exploration confirms no peritoneal metastasis and negative peritoneal lavage.
• Physical condition and adequate organ function to ensure the success of abdominal surgery.
• 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.
• Life expectancy of more than 5 years without serious concomitant diseases.
• Written (signed) informed consent.
• Able to comply with study and follow-up procedures.
• Consent to provide tissue sample.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (18)

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  PMID: 35382819 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib; XELOX

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zhaoqing Tang, MD

CONTACT

86-21-64041990; tang.zhaoqing@zs-hospital.sh.cn

Study Design

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

Study Record Dates

• First Submitted: July 22, 2017
• First Posted: July 25, 2017
• Study Start: February 1, 2017
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

CN (1)