The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Prospective，Single-center，Single-arm，Open-label exploratory clinical trial evaluating the efficacy and safety of Conversion Surgery for Apatinib plus SOX for patients with unresectable gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Apatinib; Oxaliplatin

Criteria

Inclusion Criteria:

1. Histologically proved gastric adenocarcinoma;

2. At least a unresectable factor before operation via CT, MRI, or PET-CT: difficult resection of locally advanced gastric cancer(T4b); hepatic metastasis (H1; at most five lesions, total diameter ≤8 cm); Peritoneal metastasis(CY1, P1) ;

3. Definitely diagnosed as unresectable gastric cancer via exploratory laparoscopy or laparotomy;

4. ECOG performance status 0-2;

5. Age 18-70 years old, Life expectancy estimated than 3 months;

6. For results of blood routine test and biochemical tests:

1. Hgb ≥ 80g/L,

2. WBC ≥ 4000/mm3,

3. ANC ≥ 1.5×109/L,

4. platelets ≥ 80×109/L

5. ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL（Hematogenous metastases）,

6. Serum Total bilirubin ≤ 1.5 X UNL,

7. Serum Creatine ≤ 1.5 x UNL ；

7. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease;

8. Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver);

9. informed consent.

Exclusion Criteria:

1. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class I; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction; Patients with positive urinary protein;

2. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);

3. Subjects with high gastrointestinal bleeding risk, including the following conditions:

local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;

4. Contraindications include allergy to apatinib and/or its accessories, active bleeding, intestinal perforation, intestinal obstruction, within 30 days after surgery, drugs with poor-controlled hypertension, Class Ⅲ-Ⅳ cardiac dysfunction （NYHA standard）, severe hepatic and renal dysfunction（level 4）if apatinib use is considered;

5. Abnormal Coagulation (INR>1.5, APTT>1.5 UNL), with tendency of bleed;

6. Pregnant or lactating women;

7. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;

8. Treatment with prior radiotherapy, chemotherapy, Targeted therapy or immunotherapy;

9. Other conditions regimented at investigators' discretion.