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Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

Placebos

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Peritoneal metastasis, Paclitaxol, Apatinib, Second-line chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients, aged between 18 and 75 years old;
Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1); and confirmed as peritoneal metastasis by CT scan or laparoscope
Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;
Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
Life expectancy of more than 3 months;
Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 10*9/L, neutrophil ≥1.5 × 10*9/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN)

Exclusion Criteria:

Pregnant or lactating women;
History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); 4. Uncontrolled hypertension;

5. Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure; 6. Urine protein>grade 1; 7. Any factors that influence the usage of oral administration; 8. Patients with a clear tendency of gastrointestinal bleeding; 9. Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN); 10. Abuse of alcohol or drugs; 11. Less than 4 weeks from the last clinical trial; 12. Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy; 13. Evidence of central nervous system(CNS) metastasis; 14. Disability of serious uncontrolled intercurrence infection.

Sites / Locations

Foshan people's HospitalRecruiting
Cancer center of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

Apatinib: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

The time from randomize to progression or death

Secondary Outcome Measures

Overall survival (OS)

The time from randomize to death

Objective response rate (ORR)

The rate of complete response and partial response according to RECIST guidelines

Disease control rate(DCR)

The rate of complete response , partial response and stable disease according to RECIST guidelines

Safety (incidence of adverse events) [

Incidence of adverse events

Full Information

NCT ID

NCT03144843

First Posted

May 5, 2017

Last Updated

May 5, 2017

Sponsor

Sun Yat-sen University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03144843

Brief Title

Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.

Official Title

A Phase II Multicenter, Randomized, Double-blind Study of Apatinib Combined With Paclitaxol Versus Placebo With Paclitaxol as Second Line Therapy for Advanced Gastric / Esophagogastric Junction Adenocarcinoma With Peritoneal Metastasis.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 13, 2017 (Actual)

Primary Completion Date

January 31, 2020 (Anticipated)

Study Completion Date

January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis. Patients will be randomized to one treatment arm: Arm A: apatinib 500mg qd, Paclitaxol 80mg/m2, d1, d8, d15,every 4 weeks ; Arm B: placebo 500mg qd, Paclitaxol 80mg/m2, d1, d8, d15,every 4 weeks ; Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).

Detailed Description

Gastric cancer is the second most common cause of cancer-related deaths worldwide, and most patients are diagnozed at advanced stage in China. Peritoneal metastasis is the most common metastatic site. For gastric cancer patients with peritoneal metastasis, chemotherapy can bring survival benefit versus best sportive care. Paclitaxol is the standard second line chemotherapy for advanced gastric cancer patients. Apatinib mesylate is a small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI). It has been approved as third-line treatment for patients with advanced gastric adenocarcinoma in China. This multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Gastric cancer, Peritoneal metastasis, Paclitaxol, Apatinib, Second-line chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Multicenters ramdomized double-blind phase II study.

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Apatinib: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

Paclitaxol

Intervention Description

Apatinib 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

Paclitaxol

Intervention Description

Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

The time from randomize to progression or death

Time Frame

Approximately 1 year

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

The time from randomize to death

Time Frame

Approximately 3 years

Title

Objective response rate (ORR)

Description

The rate of complete response and partial response according to RECIST guidelines

Time Frame

Approximately 1 year

Title

Disease control rate(DCR)

Description

The rate of complete response , partial response and stable disease according to RECIST guidelines

Time Frame

Approximately 1 year

Title

Safety (incidence of adverse events) [

Description

Incidence of adverse events

Time Frame

Approximately 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients, aged between 18 and 75 years old; Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ; At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1); and confirmed as peritoneal metastasis by CT scan or laparoscope Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease; Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1; Life expectancy of more than 3 months; Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy; Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 10*9/L, neutrophil ≥1.5 × 10*9/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN) Exclusion Criteria: Pregnant or lactating women; History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix; Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); 4. Uncontrolled hypertension; 5. Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure; 6. Urine protein>grade 1; 7. Any factors that influence the usage of oral administration; 8. Patients with a clear tendency of gastrointestinal bleeding; 9. Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN); 10. Abuse of alcohol or drugs; 11. Less than 4 weeks from the last clinical trial; 12. Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy; 13. Evidence of central nervous system(CNS) metastasis; 14. Disability of serious uncontrolled intercurrence infection.

Facility Information:

Facility Name

Foshan people's Hospital

City

Foshan

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Wang

Phone

075783161035

m18038863618@163.com

Facility Name

Cancer center of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fenghua Wang, MD, PhD

Phone

86-020-87342490

wangfh@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Miao-Zhen Qiu, MD, PhD

Phone

86-020-87342490

qiumzh@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Rui-Hua Xu, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.

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