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A Prospective study of Conversion Therapy Using Docetaxel Chemotherapy Plus Apatinib in Unresectable Adenocarcinoma of Esophagogastric Junction(AEG)

A Prospective study of Conversion Therapy Using Docetaxel Chemotherapy Plus Apatinib in Unresectable Adenocarcinoma of Esophagogastric Junction(AEG)

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-17012575
Enrollment
Unknown
Registered
2017-09-05
Start date
2017-02-01
Completion date
Unknown
Last updated
2017-09-11

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

Conditions

Adenocarcinoma of Esophagogastric Junction(AEG)

Interventions

Experimental group:Apatinib: 500 mg qd po, take after meals (as much as possible at the same time every day), day6-14
Docetaxel40mg/m2d1+5-FU2000mg/m2civ46h+CF300mg/m2d1
Control group:Docetaxel40mg/m2d1+5-FU2000mg/m2civ46h+CF300mg/m2d1

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years;Life expectancy = 3 months; 2. ECOG(Eastern Cooperative Oncology Group)performance status of 0 - 2; 3. The Pathological diagnosis of Adenocarcinoma of Esophagogastric Junction(AEG) 4. Using of CT or MRIPET-CT and other examination tips with 1 non removable factors: Group1: N3 lymphatic metastasis , mainly refers to the sixteenth groups of patients with lymphatic metastasis; Group 2: Extensive or fused D2 lymph nodes; Group 3: highly locally advanced, T4b; Group 4: Hepatic metastases(H1)Less than 5 of total shift range, less than 8cm in diameter; Group 5: Peritoneal metastasis(CY1,P1). 5. Did not receive any early treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) 6. During the baseline period, hemodynamic indexes (including cytometry, liver and kidney function) are normal. Such as WBC >4.0×10^9/L, neutrophil>1.5×10^9/L, platelet >100×10^9/L, total bilirubin<1.5×ULN, aspartate aminotransferase and alanine aminotransferase<1.5×ULNserum creatinine<1.2mg/dl; 7. During the baseline period, good heart function, no myocardial infarction within six months, no high blood pressure, no kidney disease, and other coronary heart disease can be controlled within the control range. 8. During the baseline period, there are no any other uncontrollable benign diseases, such as lung, kidney, liver, infection and so on; 9. Before and during the treatment, patients havent taken part in Other clinical trials; 10. Signed consent forms voluntarily.

Exclusion criteria

Exclusion criteria: 1. There are lung, brain, bone, and other distal transfer except the liver and the peritoneum; 2. Patients who have willingness to accept Hessaitin's treatment with Her-2 positive; 3. At the same time with other uncontrollable serious diseases : including atrial fibrillation, angina, cardiac insufficiency, ejection fraction less than 50%, uncontrollable hypertension(suffering from hypertension, antihypertensive drugs can not be reduced to the normal range of treatment: systolic blood pressure>140mmHg / diastolic pressure>90mmHg), renal insufficiency; 4. Patients undergoing therapy with other medications (including traditional Chinese Medicine) or can not guarantee to follow the requirements of the study; 5. Drug allergy to this study; 6. Pregnant or lactating women; 7. Women of childbearing age, fertility requirements during the study period.

Design outcomes

Primary

MeasureTime frame
R0 Resection Rate;

Secondary

MeasureTime frame
DFS;DCR;Chemotherapy Safety;OS of the 1, 3 and 5 year;

Countries

China

Contacts

Public ContactZhigang Jie

The First Affiliated Hospital of Nanchang University

jiezg123@126.com+86 13707918042

Outcome results

None listed

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