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

Gastric Cancer Clinical Trial

Official title:

The Exploratory Study of Conversion Surgery for Apatinib in Combination With Oxaliplatin/S-1(SOX) for Patients With Unresectable Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03007446
• Other study ID #: Ahead-BG301
• Status: Recruiting
• Phase: Phase 2
• First received: December 28, 2016
• Last updated: September 25, 2017
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: September 2017
• Source: Chinese PLA General Hospital
• Contact: Hongqing Xi, Master
• Phone: 010-66938128
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Gastric cancer is the second most common cause of cancer‑related deaths worldwide, and surgical resection during the early stage has improved treatment outcomes.However, many patients are diagnosed with unresectable advanced or metastatic stage disease losing the radical surgery opportunity. Systemic chemotherapy is the leading treatment that prolongs survival times for such patients.

Approximate 20 patients with unresectable gastric cancer will be enrolled in this study,the investigators will evaluate the efficacy and security of Apatinib + SOX(oxaliplatin+S-1) for unresectable gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ?-? 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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Apatinib
Apatinib :A starting dose of apatinib was administered 500 mg daily
• Oxaliplatin
Oxaliplatin:130 mg/m2,d1,ivgtt,in a 21 day cycle
• S-1
S-1:40mg,bid,d1-14,po,in a 21 day cycle.

Locations

Country	Name	City	State
China	the chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3. — View Citation

Fukuchi M, Ishiguro T, Ogata K, Suzuki O, Kumagai Y, Ishibashi K, Ishida H, Kuwano H, Mochiki E. Prognostic Role of Conversion Surgery for Unresectable Gastric Cancer. Ann Surg Oncol. 2015 Oct;22(11):3618-24. doi: 10.1245/s10434-015-4422-6. Epub 2015 Feb 7. — View Citation

Inoue K, Nakane Y, Kogire M, Fujitani K, Kimura Y, Imamura H, Tamura S, Okano S, Kwon AH, Kurokawa Y, Shimokawa T, Takiuchi H, Tsujinaka T, Furukawa H. Phase II trial of preoperative S-1 plus cisplatin followed by surgery for initially unresectable locally advanced gastric cancer. Eur J Surg Oncol. 2012 Feb;38(2):143-9. doi: 10.1016/j.ejso.2011.11.009. Epub 2011 Dec 9. — View Citation

Kanda T, Yajima K, Kosugi S, Ishikawa T, Ajioka Y, Hatakeyama K. Gastrectomy as a secondary surgery for stage IV gastric cancer patients who underwent S-1-based chemotherapy: a multi-institute retrospective study. Gastric Cancer. 2012 Jul;15(3):235-44. doi: 10.1007/s10120-011-0100-y. Epub 2011 Oct 28. — View Citation

Kitayama J, Ishigami H, Yamaguchi H, Yamashita H, Emoto S, Kaisaki S, Watanabe T. Salvage gastrectomy after intravenous and intraperitoneal paclitaxel (PTX) administration with oral S-1 for peritoneal dissemination of advanced gastric cancer with malignant ascites. Ann Surg Oncol. 2014 Feb;21(2):539-46. doi: 10.1245/s10434-013-3208-y. Epub 2013 Aug 22. — View Citation

Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5. — View Citation

Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, Lim HY, Yamada Y, Wu J, Langer B, Starnawski M, Kang YK. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2011 Oct 20;29(30):3968-76. doi: 10.1200/JCO.2011.36.2236. Epub 2011 Aug 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reaction rate		4 months
Secondary	Objective Response Rate		an expected average of 6 weeks
Secondary	Disease-free survival		an expected average of 6 weeks
Secondary	Progression-Free Survival		an expected average of 6 weeks
Secondary	Overall Survival		3 years
Secondary	adverse events		6 months