S1+ Paclitaxel (IV&IP) + Bevacizumab (IP) Versus S1+Oxaliplatin as First-line Treatment in Gastric Cancer With Malignant Ascites

  • STATUS
    Recruiting
  • End date
    Apr 30, 2022
  • participants needed
    66
  • sponsor
    China Medical University, China
Updated on 23 January 2021

Summary

The purpose of this study is to compare the efficacy of S1 plus paclitaxel (intravenous injection & intraperitoneal injection) plus bevacizumab (intraperitoneal injection) vs. S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites.

Description

This is a prospective, open-label, multicenter clinical trial, to compare the efficacy of S1 plus paclitaxel (intravenous injection & intraperitoneal injection) plus bevacizumab (intraperitoneal injection) versus S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites. A total of 66 patients who are diagnosed with gastric or gastroesophageal junctional adenocarcinoma will be allocated to receive either S1 orally administration plus paclitaxel intravenous injection & intraperitoneal injection plus bevacizumab intraperitoneal injection, or to receive S1 orally administration plus oxaliplatin intravenous injection. The primary end point is ascites response rate at 6 weeks. The secondary end points include the median overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), objective response rate (ORR), puncture free survival, volume of drainage, the quality of life (QoL) and safety.

Details
Condition Metastatic Gastric Adenocarcinoma
Treatment Paclitaxel, bevacizumab, Oxaliplatin, S1
Clinical Study IdentifierNCT03990103
SponsorChina Medical University, China
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years Age 70 years, male or female
Pathologically confirmed adenocarcinoma of the gastric or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease; with medium amount of malignant ascites which can be catheterized
Diagnostic criteria for malignant ascites (meet any of the following criteria): ascites cytology positive; or imaging or pathological confirmed peritoneal metastases
No prior anti-tumor treatment to the metastatic disease; an interval of at least 6 months from the last adjuvant chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status( PS) score 0-1
Normal major organ function, and laboratory tests must meet the following criteria: hemoglobin (HGB) 90 g/L, neutrophil count 1.5109/L, platelet count 100109/L, total bilirubin (TBil) 1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 UNL, serum creatinine (Cr) 1 UNL; creatinine clearance rate (CCr) 60 ml/min (calculated using the Cockcroft-Gault equation)
International Normalized Ratio (INR) 1.5 and partial prothrombin time (PPT) or activated partial thromboplastin time (APTT) 1.5 UNL within 7 days before enrollment
Life expectancy of at least 12 weeks
Signed informed consent (ICF)
For women of child bearing potential, a negative serum or urine pregnancy test result should be obtained with 7 days before enrollment; Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration

Exclusion Criteria

Known hypersensitivity or allergic to any of the study drugs, study drug classes, or excipients in the formulation
Subject received chemotherapy to the metastatic disease (except adjuvant/neoadjuvant chemotherapy administered 24 weeks before enrollment)
Subject with other malignancies, except for non-melanoma skin cancer or in-situ cervical carcinoma under adequate treatment, or other treated malignancies without evidence of recurrent for 5 years
Anti-tumor cytotoxic drug therapy within 14 days prior to enrollmentlonger washout time interval might needed depends on drug characteristics
Uncontrolled hypertension which cannot be reduced to normal range by antihypertensive agents [Systolic Blood Pressure(SBP) >140 mmHg, diastolic blood pressure (DBP) > 90 mmHg], coronary artery disease > grade 1, arrhythmia > grade 1 [including corrected QT(QTc) interval prolongation: QTc>450 ms for maleQTc>470 ms for female], grade 1 heart failure
Proteinuria ++or persistent proteinuria > 1.0 g/24 hours
Presence of any toxicity grade 1 according to NCI-CTCAE except for alopecia
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks, cerebral hemorrhagecerebral infarction), deep vein thrombosis and pulmonary embolism within 12 months before enrollment
Bowel obstruction within 6 weeks before enrollment
Surgical treatment was performed within 6 weeks before enrollment. Subject should recover from any major surgery
Serious uncontrolled systemic illness or medical condition or uncontrolled infections, including but not limited to: uncontrollable ventricular arrhythmias, history of documented myocardial infarction within 3 months, uncontrollable epileptic dementia, unstable spinal compression, superior vena cava syndrome, extensive bilateral interstitial pulmonary disease by high-resolution computed tomography (HRCT), or any neurological or mental abnormalities which affect compliance
Human immunodeficiency virus (HIV) positive
Pregnancy or lactation women
Cannot be orally administered medication
Subject with a tendency for gastrointestinal hemorrhage. Including: Black stool or hematemesis within 2 months; For subjects positive in occult test with unresected primary lesion, if the principle investigator in each center considers with possibility of gastrointestinal hemorrhage, the subject could not be enrolled
Subject with malignant pleural effusion need medical intervention
A history or evidence of hereditary hemorrhagic constitution or coagulation disorder that increases the risk of bleeding
Subjects with central nerve system metastases
Have been enrolled in other clinical trial with investigational drug treatment within the 4 weeks of start of study treatment
For subject with bone metastases, palliative radiotherapy was given 4 weeks before enrollment (radiation field >5%)
Any other disease or condition that the investigator considers not suitable for participating in this clinical trial
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