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

NCT03990103 | Unknown Phase 2 DMC

• 1 other identifier: CLOG1704
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Gastric Adenocarcinoma

Keywords

Gastric Carcinoma; Malignant Ascites; Intraperitoneal Chemotherapy; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Ascites response rate at 6 weeks

  response of ascites at 6 weeks

  6 weeks

Secondary Outcomes (7)

• PFS

  12 months

• OS

  2 years

• ORR

  12 months

• TTF

  12 months

• Puncture free survival

  12 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

S1+Paclitaxel (IV\&IP)+Bevacizumab (IP)

Drug: S1; Drug: Paclitaxel; Drug: Bevacizumab

Control arm

ACTIVE COMPARATOR

S1+Oxaliplatin (IV)

Drug: S1; Drug: Oxaliplatin

Interventions

S1 DRUG

80-120 mg/day, PO, D1-14, every 21 days

Also known as: Tegafur Gimeracil Oteracil Potassium Capsule

Control arm; Experimental arm

Paclitaxel DRUG

20 mg/m2/day, IP, D1-3; 50 mg/m2, IV, D1; 70 mg/m2, IV, D8; every 21 days

Also known as: Paclitaxel Injection

Experimental arm

Bevacizumab DRUG

200 mg, IP, D1, every 21 days

Also known as: Avastin ®

Experimental arm

Oxaliplatin DRUG

130 mg/m2, IV, D1, every 21 days

Also known as: ELOXATIN®

Control arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 1.5×109/L, platelet count ≥ 100×109/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.

You may not qualify if:

• 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 enrollment（longer 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 \[including corrected QT(QTc) interval prolongation: QTc\>450 ms for male，QTc\>470 ms for female\], 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 hemorrhage、cerebral 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); Paclitaxel; Bevacizumab; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes

Study Officials

• Yunpeng Liu, M.D.

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Liu, M.D.

CONTACT

86-24-83282312; cmu_trial@163.com

Xiujuan Qu, M.D.

CONTACT

86-24-83282312; cmuquxiujuan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 18, 2019
• Study Start: November 1, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2022
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

CN (1)