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

Gastric Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03144843
• Other study ID #: Apatinib_GC
• Status: Recruiting
• Phase: Phase 2
• First received: May 5, 2017
• Last updated: May 5, 2017
• Start date: January 13, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Adult patients, aged between 18 and 75 years old;

2. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;

3. 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

4. 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;

5. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;

6. Life expectancy of more than 3 months;

7. 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;

8. 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:

1. Pregnant or lactating women;

2. History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;

3. 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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Foshan people's Hospital	Foshan	Guangdong
China	Cancer center of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	The time from randomize to progression or death	Approximately 1 year
Secondary	Overall survival (OS)	The time from randomize to death	Approximately 3 years
Secondary	Objective response rate (ORR)	The rate of complete response and partial response according to RECIST guidelines	Approximately 1 year
Secondary	Disease control rate(DCR)	The rate of complete response , partial response and stable disease according to RECIST guidelines	Approximately 1 year
Secondary	Safety (incidence of adverse events) [	Incidence of adverse events	Approximately 1 year