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Metastatic Gastric AdenocarcinomaPhase 2NCT03990103

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

A Phase 2 study testing S1, Paclitaxel and Bevacizumab in people with Metastatic Gastric Adenocarcinoma, run by China Medical University, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Metastatic Gastric Adenocarcinoma
What is being tested?
S1, Paclitaxel and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
1 Nov 2017to 30 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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).
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  • 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.

Who cannot join

  • 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
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  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Yunpeng Liu, M.D. contact

86-24-83282312

cmu_trial@163.com

Xiujuan Qu, M.D. contact

86-24-83282312

cmuquxiujuan@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Yunpeng Liu, Ph.D

    Xiujuan Qu, M.D.

    Recruiting

Other trials in China

About this study

Official title: S1 Plus Paclitaxel (IV&IP) Plus Bevacizumab (IP) Versus S1 Plus Oxaliplatin(IV) as First-line Treatment in Gastric or Gastroesophageal Junctional Adenocarcinoma With Malignant Ascites: An Open-label, Multicenter Phase II Study

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.

Read the detailed 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.

Keywords
Gastric Carcinoma, Malignant Ascites, Intraperitoneal Chemotherapy, Bevacizumab
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S1Drug

    Also called Tegafur Gimeracil Oteracil Potassium Capsule

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

  • PaclitaxelDrug

    Also called Paclitaxel Injection

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

  • BevacizumabDrug

    Also called Avastin ®

    200 mg, IP, D1, every 21 days

  • OxaliplatinDrug

    Also called ELOXATIN®

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

Study groups in NCT03990103
Study groupRoleWhat they receive
Experimental armExperimentalS1+Paclitaxel (IV\&IP)+Bevacizumab (IP)
Receives: Drug: S1; Drug: Paclitaxel; Drug: Bevacizumab
Control armActive comparatorS1+Oxaliplatin (IV)
Receives: Drug: S1; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ascites response rate at 6 weeks

    response of ascites at 6 weeks

    Measured: 6 weeks

Secondary outcomes (7)

  1. PFS

    Progression-free survival,From 1st drug administration to the date of first progression or date of death (whichever occurs first)

    Measured: 12 months

  2. OS

    Overall survival, from enrollment until death from any cause

    Measured: 2 years

  3. ORR

    Objective response rate, the proportion of patients with reduction in tumor burden of a predefined amount

    Measured: 12 months

  4. TTF

    Time to treatment failure, from 1st drug administration to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death

    Measured: 12 months

  5. Puncture free survival

    Puncture free survival time, from the first puncture to secondary puncture

    Measured: 12 months

  6. Volume of drainage

    Volume of drainage

    Measured: 12 months

  7. Adverse events

    Adverse events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start1 Nov 2017
  3. Primary completion30 Apr 2021 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03990103
Sponsor's protocol ID
CLOG1704
Status last verified
Jun 2019
First submitted
28 May 2019
Last updated
19 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: not yet decided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S1, Paclitaxel and Bevacizumab in people with Metastatic Gastric Adenocarcinoma, run by China Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunpeng Liu, M.D. (86-24-83282312, cmu_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ascites response rate at 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03990103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.

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