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Multicenter prospective randomized controlled clinical study of Apatinib combined with FLOT perioperative Chemotherapy and surgery for treatment of III stage Advanced Gastric Cancer

Multicenter prospective randomized controlled clinical study of Apatinib combined with FLOT perioperative Chemotherapy and surgery for treatment of III stage Advanced Gastric Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012911
Enrollment
Unknown
Registered
2017-10-09
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastric Cancer

Interventions

treatment group:Apatinib+FLOT

Sponsors

Liaoning Cancer Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with histologically confirmed locally advanced adenocarcinoma of the stomach or EGJ; A clinical III stage was undertaken by ultrasonic endoscope/contrast-enhanced CT/MR without surgical contraindications; Age ranges from 18 to 75 years; Eastern Cooperative Oncology Group(ECOG) performance status of one or less; No prior antineoplastic therapy; Patients were tolerated of surgical III grade; WBC>4.0×10/L,ANC>1.5 ×10^9/L, Hb=100g/L, PLT=100×10^9/L, serumbilirubin=1.5×ULN, AST, ALT=2.5ULN, Cr=1.0×ULN; No other current or previous malignancy; Abide by the plan; Offer informed consent in writing and understand no loss profit after quiting; the expected survival =6 mouths

Exclusion criteria

Exclusion criteria: Distant metastasis and unresectable; Other current or previous malignancy, but curative skin basal cell carcinoma and carcinoma in situ of cervix were excluded; Her-2 positive and accept the related therapy; Known hypersensitivity to FU, leucovorin, oxaliplatin, docetaxel; Pregnant or breast feeding; Having antineoplastic therapy; Serious or no uncontrolled medical diseases and infection; Major organ failure such decompensated heart, lung, liver, kidney failure; With surgical contraindications; Gastrointestinal bleeding and/or coagulation disorders;Entered other study; HBV or HCV was active?; Peripheral neuropathy of NCI grade=2 at baseline

Design outcomes

Primary

MeasureTime frame
resectable rate(R0,R1,R2);pathologic complete response;safety;

Secondary

MeasureTime frame
Disease-Free Time;Overall Survival, OS;recurrence rate;

Countries

China

Contacts

Public ContactZheng Zhichao
drzhengzhichao@126.com+86 18900918181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026