A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction

Gastroesophageal Junction Adenocarcinoma Clinical Trial

Official title:

A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03349866
• Other study ID #: HRA-G01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 30, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2020
• Source: Hebei Medical University
• Contact: Qun Zhao
• Phone: 13930162111
• Email: Zhaoqun516[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 negative adenocarcinoma at gastroesophageal junction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age:18 to 70 years old (man or female);

2. Con?rmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter =8 cm by gastroscopy and CT, The her-2 negative was detected by immunohistochemistry;

3. Patients with Stage for ? by CT/MRI (According to the eighth edition of AJCC );

4. Patients with measurable lesions(measuring=10mm on spiral CT scan, satisfying the criteria in RECIST1.1);

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

6. Major organ function has to meet the following certeria:

HB=80g/L; ANC=1.5×109/L; PLT=90×109/L; ALT and AST=2.5×ULN, but<=5×ULN if the transferanse elevation is due to liver metastases; TBIL<1.5×ULN; Serum creatinine =1.5×ULN;

7. Life expectancy greater than or equal to 6 months;

8. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;

9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Allergic to apatinib, capecitabine and oxaliplatin;

2. The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive;

3. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), Uncontrolled coronary heart disease and arrhythmia ,class?-?cardiac insufficiency;

4. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);

5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;

6. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency;

7. Pregnant or lactating women;

8. Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);

9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;

10. Less than 4 weeks from the last clinical trial;

11. The researchers think inappropriate.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Intervention

Drug:
• apatinib
apatinib:250mg qd po
• Capecitabine
1000mg/m2 bid d1-14
• Oxaliplatin
130 mg/m2 Ivgtt d1 q3w

Radiation:
• Radiotherapy
45Gy/25f (1.8Gy/f/d,5 f/w)

Locations

Country	Name	City	State
China	The Fourth Hospital of Hebei Medical University	ShiJiaZhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pathological complete response rate(pCR)	The lesion disappeared completely by pathology	within 3 weeks after surgery
Secondary	Objective response rate (ORR)	Baseline to measured stable disease	within 3 weeks after surgery
Secondary	R0-resection rate	There was no residual by the microscope	within 3 weeks after surgery
Secondary	Disease-free survival(DFS)	Baseline to measured date of recurrence or death from any cause	3 year
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	3years
Secondary	Adverse events	Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.	3 year