The Clinical Research of Mesylate Apatinib Combined With Docetaxel and S-1 as the First-line Treatment of Metastatic Gastric Cancer

NCT ID: NCT03154983

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2021-12-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with docetaxel and S-1 as the first-line treatment of metastatic gastric cancer.

Conditions

Metastatic Gastric Cancer

Keywords

Mesylate Apatinib; The First-line Treatment; Metastatic Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First-line treatment

First-line treatment：treatment including Mesylate Apatinib Combined With Docetaxel and S-1(DS).DS Docetaxel 75mg/m2 d1 iv.drop 1h（one hour）， S-1(BSA\<1.25 40mg Po bid(twice a day), BSA \>=1.25-\<1.5 50mg Po bid, BSA \>=1.5 60mg Po bid), Q21d(21 days a cycle); Mesylate Apatinib 500mg Po QD(once a day) continuous use; until disease deterioration.

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

Diagnosed with metastatic gastric cancer patients (including the esophagogastric junction adenocarcinoma), DS(docetaxel and Tegafur)and Mesylate apatinib 6 cycles, the specific amount of usage: DS Docetaxel 75mg/m2 D1 IV.drop 1H（one hour）, Tegafur(BSA\<1.25 40mg Po bid(twice a day), BSA \>=1.25-\<1.5 50mg Po bid, BSA \>=1.5 60mg Po bid, Q21d(21 days a cycle)); Mesylate Apatinib 500mg Po QD（once a day)） continuous use, until disease deterioration.

Interventions

docetaxel

Diagnosed with metastatic gastric cancer patients (including the esophagogastric junction adenocarcinoma), DS(docetaxel and Tegafur)and Mesylate apatinib 6 cycles, the specific amount of usage: DS Docetaxel 75mg/m2 D1 IV.drop 1H（one hour）, Tegafur(BSA\<1.25 40mg Po bid(twice a day), BSA \>=1.25-\<1.5 50mg Po bid, BSA \>=1.5 60mg Po bid, Q21d(21 days a cycle)); Mesylate Apatinib 500mg Po QD（once a day)） continuous use, until disease deterioration.

Intervention Type: DRUG

Other Intervention Names

Tegafur; Mesylate Apatinib

Eligibility Criteria

Inclusion Criteria

1. Age: 18-70 years of age;

2. recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction diagnosed by pathology (including histology or cytology);

3. 1 measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST(Response Evaluation Criteria In Solid Tumors）1.1;

4. had not received other anti VEGFR targeted therapy;

5. ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-2 scores;

6. the expected survival time is more than 3 months;

7. if patient had accepted the chemotherapy, the time from the last chemotherapy should be more than 6 months;

8. the damage caused by other treatments has been restored, and the subjects received radiotherapy or surgery over 4 weeks ago, and the wound has healed completely;

9. the main organ function is normal, which should meet the following criteria: (1) blood routine examination standards should be met: (no blood transfusion within 14 days) A. HB（hemoglobin） = 90g/L, B. ANC(absolute neutrophil count) = 1.5 * 109/L, C. PLT（platelet） = 80 * 109/L; (2) biochemical examination shall comply with the following criteria: A. BIL（bilirubin） <1.25 normal upper limit (ULN), B. ALT（glutamic-pyruvic transaminase） and AST（glutamic-oxalacetic transaminase）<2.5ULN（upper limit of normal）, if subjects have liver metastases, the ALT and AST <5ULN（upper limit of normal）, C. Cr ≤ 1ULN, CCR（creatinine clearance rate） > 50ml/min (Cockcroft-Gault formula);

10. women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test;

11. participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.

Exclusion Criteria

1. Suffering from other malignant tumors previously or at the same time, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ;

2. Patients have used the paclitaxel class and / or S-1 as the adjuvant therapy in 2;

3. have been confirmed to be allergic to docetaxel, 5-fluorouracil, apatinib and / or its accessories;

4. the blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg);

5. patients are suffering from severe cardiovascular disease: the II level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc(corrected QT interval) prolongation of male > 450 ms, of female > 470ms ); and patients have III-IV grade of cardiac insufficiency, or left ventricular (LVEF) < 50% shown by echocardiography according to the NYHA(New York Heart Association) standard;

6. patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g);

7. have a variety of factors that affect oral drugs (such as difficulty in swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);

8. patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage;

9. coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;

10. patients with a history of psychotropic substance abuse and unable to give up or have mental disorders;

11. Patients who participated in other clinical trials within 4 weeks;

12. have received the VEGFR inhibitors, such as sorafenib and sunitinib;

13. according to the researcher's judgment, there are other accompanying disease endangering the patient's safety or affect the patient to complete the study.

14. patients with central nervous system metastasis;

15. pregnant or lactating women;

16. the researchers consider those who were not suitable for inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hubei Cancer Hospital

OTHER

Sponsor Role: collaborator

Huangshi Central Hospital

OTHER

Sponsor Role: collaborator

The Central Hospital of Huanggang

OTHER

Sponsor Role: collaborator

Xianning Central Hospital

OTHER

Sponsor Role: collaborator

Taihe Hospital

OTHER

Sponsor Role: collaborator

The first hospital of Zaoyang

UNKNOWN

Sponsor Role: collaborator

Hanchuan City people's Hospital

UNKNOWN

Sponsor Role: collaborator

Yangxin People's Hospital

UNKNOWN

Sponsor Role: collaborator

Tianmen People's Hospital

UNKNOWN

Sponsor Role: collaborator

Zhou Fuxiang

OTHER

Sponsor Role: lead

Responsible Party

Zhou Fuxiang

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fuxiang Zhou, M.D.

Role: STUDY_CHAIR

Wuhan University

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ling Xia, M.D.

Role: CONTACT

Phone: 18971250716

Email: 82425583@qq.com

Facility Contacts

Fuxiang Zhou, M.D.

Role: primary

Ling Xia, M.D.

Role: backup

Other Identifiers

HCCSC G04

Identifier Type: -

Identifier Source: org_study_id