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

NCT03007446 | Unknown Phase 2 DMC

• 1 other identifier: Ahead-BG301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Apatinib; SOX; Conversion Surgery; unresectable gastric cancer

Outcome Measures

Primary Outcomes (1)

• reaction rate

  4 months

Secondary Outcomes (5)

• Objective Response Rate

  an expected average of 6 weeks

• Disease-free survival

  an expected average of 6 weeks

• Progression-Free Survival

  an expected average of 6 weeks

• Overall Survival

  3 years

• adverse events

  6 months

Study Arms (1)

Apatinib plus Oxaliplatin/S-1

EXPERIMENTAL

1. Apatinib : A starting dose of apatinib was administered 500 mg daily on days 1 through 21 of each 3-week cycle. 2. Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle. 3. S-1:40mg，bid，d1-14，po，in a 21 day cycle.

Drug: Apatinib; Drug: Oxaliplatin; Drug: S-1

Interventions

Apatinib DRUG

Apatinib :A starting dose of apatinib was administered 500 mg daily

Also known as: Apatinib mesylate tablets

Apatinib plus Oxaliplatin/S-1

Oxaliplatin DRUG

Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle

Apatinib plus Oxaliplatin/S-1

S-1 DRUG

S-1:40mg，bid，d1-14，po，in a 21 day cycle.

Apatinib plus Oxaliplatin/S-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proved gastric adenocarcinoma;
• 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) ;
• Definitely diagnosed as unresectable gastric cancer via exploratory laparoscopy or laparotomy;
• ECOG performance status 0-2;
• Age 18-70 years old, Life expectancy estimated than 3 months;
• For results of blood routine test and biochemical tests:
• Hgb ≥ 80g/L,
• WBC ≥ 4000/mm3,
• ANC ≥ 1.5×109/L,
• platelets ≥ 80×109/L
• ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL（Hematogenous metastases）,
• Serum Total bilirubin ≤ 1.5 X UNL,
• Serum Creatine ≤ 1.5 x UNL ；
• Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease;
• Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver);

You may not qualify if:

• 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;
• Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• 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;
• 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;
• Abnormal Coagulation (INR\>1.5, APTT\>1.5 UNL), with tendency of bleed;
• Pregnant or lactating women;
• Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
• Treatment with prior radiotherapy, chemotherapy, Targeted therapy or immunotherapy;
• Other conditions regimented at investigators' discretion.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

the chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Related 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.

  PMID: 24094768 BACKGROUND

• 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.

  PMID: 25663597 BACKGROUND

• 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.

  PMID: 22033890 BACKGROUND

• 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.

  PMID: 23975319 BACKGROUND

• 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.

  PMID: 22154885 BACKGROUND

• 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.

  PMID: 21844504 BACKGROUND

• 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.

  PMID: 23918952 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib; Oxaliplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Lin Chen

  the Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongqing Xi, Master

CONTACT

010-66938128

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the General Surgery Department, Chinese PLA General Hospital

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 2, 2017
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 27, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)