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Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT04047953
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaode Bu, Beijing Cancer Hospital

Brief Summary:
To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Initial Unresectable Local Advanced or Potentially Resectable Metastatic Gastric Adenocarcinoma
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conversion Therapy
Paclitaxel (albumin-bound) +S-1+Oxaliplatin
Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1
Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40~60mg,bid, d1-14( BSA<1.25m2,40mg;1.25m2≤BSA≤1.5m2,50mg;BSA>1.5m2,60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD and decided by the investigator to continue the treatment for two cycles or directly.
Other Names:
  • Paclitaxel (albumin-bound) + Oxaliplatin + S-1
  • Nab-paclitaxel + Oxaliplatin + S-1




Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: within 4 weeks following the operation ]
    Proportion of patients who achieved R0 resection


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 5 years ]
    the time from registration to the date of disease progression or death resulting from any cause.

  2. overall survival (OS) [ Time Frame: 5 years ]
    the time from registration to the date of death resulting from any cause or the last follow-up visit.

  3. Adverse Events(AEs) [ Time Frame: until 28 days after the last study drug administration ]
    AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18-75 years; male or female.
  • Karnofsky Performance Status Score ≥70.
  • Histological diagnosis of gastric adenocarcinoma, HER2 expression negative.
  • The initial unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma, potentially resectable factor includes a single liver metastases, localized abdominal para-aortic lymph node (16a1 / b2) metastasis or positive abdominal free cancer cells.
  • Physical condition and organ function allow for larger abdominal surgery.
  • Subject baseline blood routine and blood biochemistry indexes meet the following criteria: hemoglobin(HB) ≥90 g/L; absolute neutrophil count(ANC) ≥1.5×109 /L; platelet count(PLT) ≥100×109 /L; alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN); total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); Serum albumin≥30g/L.
  • Echocardiographic scan confirmed left ventricular ejection fraction (LVEF) ≥ 50%.
  • No serious accompanying disease lead to a survival period of <5 years.
  • Agree and be able to follow the protocol during the study period.
  • Written informed consent was provided prior to the study screening and the patient was informed that the study could be withdrawn at any time during the study without any loss.

Exclusion Criteria:

  • For the treatment of the gastric cancer, patients who have received cytotoxic chemotherapy, radiotherapy or immunotherapy, except corticosteroids.
  • Pregnancy or breastfeeding woman.
  • Women of childbearing age who had a positive pregnancy test at baseline or who did not undergo a pregnancy test. Menopausal women must be stopped for at least 12 months to ensure that no pregnancy is possible.
  • Men and women who have sex (with fertility probability) are reluctant to contraception during the study.
  • Patients with ascites and positive abdominal free cancer cells.
  • There are other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
  • Those with a history of epilepsy, central nervous system disease, or mental disorder may be judged by the investigator that their clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
  • Clinically severe (active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe drug-affected arrhythmias, or there is a history of myocardial infarction in the last 12 months.
  • Upper gastrointestinal stagnation or abnormal physiological function or malabsorption syndrome may affect the absorption of S-1.
  • It is known to have peripheral neuropathy ≥ NCI CTC AE grade 2. However, only the deep sputum reflex (DTR) disappears and the patient does not have to be excluded.
  • Organ transplantation requires immunosuppressive therapy.
  • Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases.
  • Moderate or severe renal impairment [creatinine clearance equal to or lower than 50ml/min (calculated according to Cockcroft and Gault equations), or serum creatinine > upper normal limit (ULN).
  • Those suffering from dihydropyrimidine dehydrogenase (DPD) deficiency are known.
  • Those who are allergic to taxanes or any research ingredients.
  • Those who received research medications or preparations/treatments (ie, participated in other trials) within 4 weeks prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047953


Contacts
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Contact: Jiafu ji, MD 86-010-88196048 jiafuj@hotmail.com
Contact: Zhaode Bu, MD 86-010-88196945 buzhaode@cjcrcn.org

Locations
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China, Beijing
Beijing Cancer Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Jiafu Ji, MD    86-010-88196048    jiafuj@hotmail.com   
Contact: Zhaode Bu, MD    86-010-88196945    buzhaode@cjcrcn.org   
Principal Investigator: Jiafu Ji, MD         
Principal Investigator: Zhaode Bu, MD         
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Principal Investigator: Jiafu ji, MD Beijing Cancer Hospital
Principal Investigator: Zhaode Bu, MD Beijing Cancer Hospital

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Responsible Party: Zhaode Bu, Clinical Professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT04047953     History of Changes
Other Study ID Numbers: GC-conversion
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaode Bu, Beijing Cancer Hospital:
Paclitaxel (albumin-bound)
gastric cancer
conversion therapy
Additional relevant MeSH terms:
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Oxaliplatin
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action