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

NCT03144843 | Unknown Phase 2

• 1 other identifier: Apatinib_GC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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).

Conditions

Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The time from randomize to progression or death

  Approximately 1 year

Secondary Outcomes (4)

• Overall survival (OS)

  Approximately 3 years

• Objective response rate (ORR)

  Approximately 1 year

• Disease control rate(DCR)

  Approximately 1 year

• Safety (incidence of adverse events) [

  Approximately 1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Apatinib

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Apatinib DRUG

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

Also known as: Paclitaxol

Experimental group

Placebos DRUG

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

Also known as: Paclitaxol

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;
• \. 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

Foshan people's Hospital

Foshan, Guangdong, China

RECRUITING

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicenters ramdomized double-blind phase II study.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: January 13, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)