Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
Primary Purpose
Gastric Adenocarcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring Paclitaxel (albumin-bound), gastric cancer, conversion therapy
Eligibility 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Written informed consent was provided prior to the study screening and the patient was informed that the study could be withdrawn at any time during the study without any loss.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.
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Conversion Therapy
Arm Description
Paclitaxel (albumin-bound) +S-1+Oxaliplatin
Outcomes
Primary Outcome Measures
R0 resection rate
Proportion of patients who achieved R0 resection
Secondary Outcome Measures
Progression free survival (PFS)
the time from registration to the date of disease progression or death resulting from any cause.
overall survival (OS)
the time from registration to the date of death resulting from any cause or the last follow-up visit.
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Full Information
NCT ID
NCT04047953
First Posted
August 6, 2019
Last Updated
April 4, 2023
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT04047953
Brief Title
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
Paclitaxel (albumin-bound), gastric cancer, conversion therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conversion Therapy
Arm Type
Experimental
Arm Description
Paclitaxel (albumin-bound) +S-1+Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1
Other Intervention Name(s)
Paclitaxel (albumin-bound) + Oxaliplatin + S-1, Nab-paclitaxel + Oxaliplatin + S-1
Intervention Description
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.
Primary Outcome Measure Information:
Title
R0 resection rate
Description
Proportion of patients who achieved R0 resection
Time Frame
within 4 weeks following the operation
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
the time from registration to the date of disease progression or death resulting from any cause.
Time Frame
5 years
Title
overall survival (OS)
Description
the time from registration to the date of death resulting from any cause or the last follow-up visit.
Time Frame
5 years
Title
Adverse Events(AEs)
Description
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Time Frame
until 28 days after the last study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiafu ji, MD
Phone
86-010-88196048
Email
jiafuj@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaode Bu, MD
Phone
86-010-88196945
Email
buzhaode@cjcrcn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiafu ji, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhaode Bu, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, MD
Phone
86-010-88196048
Email
jiafuj@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhaode Bu, MD
Phone
86-010-88196945
Email
buzhaode@cjcrcn.org
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, MD
First Name & Middle Initial & Last Name & Degree
Zhaode Bu, MD
12. IPD Sharing Statement
Learn more about this trial
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
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