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Status unknownNCT03007446Updated Sep 27, 2017

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

A Phase 2 interventional study of Apatinib and Oxaliplatin in Gastric Cancer, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-09-27.

Sponsored by Chinese PLA General Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Gastric Cancer

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Keywords

  • Apatinib
  • SOX
  • Conversion Surgery
  • unresectable gastric cancer
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 20 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Apatinib plus Oxaliplatin/S-1

    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

  • DrugApatinib

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

    Also known as: Apatinib mesylate tablets

  • DrugOxaliplatin

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

  • DrugS-1

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

06

What researchers measure

Primary outcomes

  1. reaction rate

    Time frame: 4 months

Secondary outcomes

  1. Objective Response Rate

    Time frame: an expected average of 6 weeks

  2. Disease-free survival

    Time frame: an expected average of 6 weeks

  3. Progression-Free Survival

    Time frame: an expected average of 6 weeks

  4. Overall Survival

    Time frame: 3 years

  5. adverse events

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • the chinese PLA General Hospital
    Beijing, 100853, China
    • Lin Chen, Master · Contact · 13801290395
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24094768 ↗
  • 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. PubMed 25663597 ↗
  • 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. PubMed 22033890 ↗
  • 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. PubMed 23975319 ↗
  • 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. PubMed 22154885 ↗
  • 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. PubMed 21844504 ↗
  • 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. PubMed 23918952 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03007446
Lead sponsor
Chinese PLA General Hospital
Responsible party
Lin Chen (Director of the General Surgery Department, Chinese PLA General Hospital, Chinese PLA General Hospital) — Principal investigator
First posted
Jan 2, 2017
Start date
Nov 2016
Primary completion
Nov 2018 (estimated)
Completion
Nov 2018 (estimated)
Last update
Sep 27, 2017

Study contacts

Hongqing Xi, Master
Contact
010-66938128
Lin Chen
principal investigator · the Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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