XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma

Gastric Carcinoma Clinical Trial

Official title:

A Phase I/II Clinical Study to Compare Postoperative Chemotherapy of Oxaliplatin With Capecitabine（XELOX）Combined With APATINIB as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03599778
• Other study ID #: AHTH-201
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2018
• Est. completion date: January 30, 2025

Study information

• Verified date: July 2018
• Source: Anhui Provincial Hospital
• Contact: Xinyang He, master
• Phone: 13505518319
• Email: HXY2333[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine（XELOX）combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection

Description:

Stage 1 (phase I tolerance study) : 12 patients were enrolled in the dose-climbing study:According to the principle of dose-climbing test,todetermine the subjects' MTD, with the following three dose levels:

• Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 250 mg, qd x180d; ②. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 375 mg, qd x180d; ③. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 500 mg, qd x180d;

Stage 2 (phase II exploratory study) :

①.Test group: subjects received 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib maximum tolerated dose

②.Control group: Subjects received 8 cycles of XELOX regimen after surgery (capecitabine:

1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w).

Eligible patients will receive 8 cycles of postoperative adjuvant therapy and will be followed up to death

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. ECOG score is 0-1;

2. Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);

3. Postoperative histology confirmed gastric adenocarcinoma;

4. The pathological stage of gastric cancer is ?A-?C stage (8th AJCC TNM);

5. Subjects' baseline blood routine and biochemical indicators meet the following standards:

• ANC=1.5×109/L;

• Hb=90g/L;

• PLT=100×109/L;

• TBIL=1.5×ULN;

• ALT and AST=2×ULN;

• Cr=1.5×ULN

• INR:1.0~1.5; APTT is within the normal range

6. The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease;

7. Sign informed consent.

Exclusion Criteria:

1. Patients with severe hypertension and poor drug control;

2. Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;

3. Patients with previous bradycardia or prolonged QT interval;

4. Patients with postoperative gastrointestinal fistula and wound rupture;

5. Known allergy to capecitabine or oxaliplatin, or metabolic disorder;

6. Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before;

7. Patients Using other experimental drugs at the same time or joining in other clinical trials.

8. Patients with severe liver diseases (such as liver cirrhosis), nephropathy, respiratory diseases or chronic systemic diseases such as uncontrollable diabetes and hypertension; Clinical symptoms of heart disease,such as congestive heart failure,coronary heart disease symptoms, arrhythmia, hypertension,that hard to control,or having myocardial infarction attack in six months or cardiac insufficiency.

9. Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• Apatinib
XELOX + apatinib's MTD

Locations

Country	Name	City	State
China	Anhui Provincial Cancer Hospital	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	Disease-free survival (DFS) is defined as the time from the beginning of treatment to Disease recurrence or death due to Disease progression	3 months