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A Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer

Primary Purpose

Gastric Adenocarcinoma, Adenocarcinoma of Gastroesophageal Junction

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel for injection (Albumin-bound)
Taxotere
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring gastric adenocarcinoma, gastroesophageal junction adenocarcinoma,Docetaxel,Albumin-bound

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18-75 (inclusive) (Whichever is on the day of signing the informed consent form). Willing to sign the informed consent form, willing and able to follow the program to accept visits, treatment and laboratory tests. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction after receiving at least first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy). Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment. Adequate main organ function. Eastern Cooperative Oncology Group (ECOG) score 0-1. Expected lifetime≥ 3 months. Female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to randomization; patients must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women are not breastfeeding; male patients must agree to contraception and refuse sperm donation. At least one assessable lesion according to RECIST V1.1; The area should not have received radiotherapy in the past, or there is evidence that the lesion has made definite progress after radiotherapy. Exclusion Criteria: Other active malignant tumors in the first 5 years of randomization. Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 7 days before randomization. Patients with central nervous system metastasis. Patients whose previous medical history shows dMMR/MSI-H and who have not received immunotherapy in the past are not suitable for enrollment, and those whose dMMR/MSI status is unknown need to clarify the status before enrolment. Patients who have used paclitaxel/docetaxel in the past (except patients with disease progression more than one year after neoadjuvant/adjuvant treatment with paclitaxel/docetaxel). History of serious cardiovascular disease within 6 months before randomization. History of gastrointestinal perforation and/or fistula within 6 months before randomization. Hypertension with poor control during the screening period. Patients with active hepatitis B, hepatitis C or HIV. Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy. Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization. Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0). Major organ surgery (except puncture biopsy) within 28 days before randomization. Have received chemotherapy, radiotherapy, targeted therapy, immunotherapy or other anti-tumor treatment of clinical research drugs within 28 days before randomization. Have received traditional Chinese medicine with anti-tumor indications within 14 days before randomization. Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization. Allergic to and / or contraindication to albumin or docetaxel. Known allergy and/or contraindication to glucocorticoids. Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence / alcohol dependence. Other situations that the researcher thinks are not suitable for participating in this study. Patients participated in another clinical study at the same time, unless it is an observational (non intervention) clinical study or is in the follow-up period of an intervention study.

Sites / Locations

  • Ethics Committee of Sun-Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Docetaxel for Injection (Albumin-bound)

Taxotere

Arm Description

Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks.

Taxotere will be administrated by intravenous infusion once every 3 weeks.

Outcomes

Primary Outcome Measures

Progression-Free-Survival (PFS)
The duration is from the randomized time to disease progression or death due to any reason.

Secondary Outcome Measures

Overall response rate (ORR)
The primary endpoint is objective response rate,which equals CR+PR.
Disease control rate (DCR)
The primary endpoint is Disease Control rate,which equals CR+PR+SD.
Duration of Response (DoR)
The time from the first assessment of tumor as CR or PR to the first assessment as PD or death from any cause
Overall survival (OS)
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost
Incidence of AE and SAE

Full Information

First Posted
November 22, 2022
Last Updated
January 27, 2023
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05705635
Brief Title
A Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer
Official Title
A Multicenter, Randomized, Controlled Phase II Clinical Study of Comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in Second-line or Above Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
Detailed Description
One hundred patients with locally advanced or metastatic gastric adenocarcinoma or gastric esophageal junction adenocarcinoma will be randomly assigned to the test group or the control group. All patients will receive Docetaxel for injection (Albumin-bound) or Taxotere for treatment until disease progression. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma, Adenocarcinoma of Gastroesophageal Junction
Keywords
gastric adenocarcinoma, gastroesophageal junction adenocarcinoma,Docetaxel,Albumin-bound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel for Injection (Albumin-bound)
Arm Type
Experimental
Arm Description
Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks.
Arm Title
Taxotere
Arm Type
Active Comparator
Arm Description
Taxotere will be administrated by intravenous infusion once every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Docetaxel for injection (Albumin-bound)
Intervention Description
Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Taxotere
Intervention Description
Taxotere, by intravenous infusion, every 3 weeks.
Primary Outcome Measure Information:
Title
Progression-Free-Survival (PFS)
Description
The duration is from the randomized time to disease progression or death due to any reason.
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
The primary endpoint is objective response rate,which equals CR+PR.
Time Frame
Up to approximately 2 years
Title
Disease control rate (DCR)
Description
The primary endpoint is Disease Control rate,which equals CR+PR+SD.
Time Frame
Up to approximately 2 years
Title
Duration of Response (DoR)
Description
The time from the first assessment of tumor as CR or PR to the first assessment as PD or death from any cause
Time Frame
Up to approximately 2 years
Title
Overall survival (OS)
Description
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost
Time Frame
Up to approximately 2 years
Title
Incidence of AE and SAE
Time Frame
Up to approximately 2 years
Other Pre-specified Outcome Measures:
Title
Plasma concentration of docetaxel (free and total)
Time Frame
At the end of Cycle 1(each cycle is 21 days)

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: 18-75 (inclusive) (Whichever is on the day of signing the informed consent form). Willing to sign the informed consent form, willing and able to follow the program to accept visits, treatment and laboratory tests. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction after receiving at least first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy). Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment. Adequate main organ function. Eastern Cooperative Oncology Group (ECOG) score 0-1. Expected lifetime≥ 3 months. Female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to randomization; patients must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women are not breastfeeding; male patients must agree to contraception and refuse sperm donation. At least one assessable lesion according to RECIST V1.1; The area should not have received radiotherapy in the past, or there is evidence that the lesion has made definite progress after radiotherapy. Exclusion Criteria: Other active malignant tumors in the first 5 years of randomization. Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 7 days before randomization. Patients with central nervous system metastasis. Patients whose previous medical history shows dMMR/MSI-H and who have not received immunotherapy in the past are not suitable for enrollment, and those whose dMMR/MSI status is unknown need to clarify the status before enrolment. Patients who have used paclitaxel/docetaxel in the past (except patients with disease progression more than one year after neoadjuvant/adjuvant treatment with paclitaxel/docetaxel). History of serious cardiovascular disease within 6 months before randomization. History of gastrointestinal perforation and/or fistula within 6 months before randomization. Hypertension with poor control during the screening period. Patients with active hepatitis B, hepatitis C or HIV. Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy. Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization. Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0). Major organ surgery (except puncture biopsy) within 28 days before randomization. Have received chemotherapy, radiotherapy, targeted therapy, immunotherapy or other anti-tumor treatment of clinical research drugs within 28 days before randomization. Have received traditional Chinese medicine with anti-tumor indications within 14 days before randomization. Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization. Allergic to and / or contraindication to albumin or docetaxel. Known allergy and/or contraindication to glucocorticoids. Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence / alcohol dependence. Other situations that the researcher thinks are not suitable for participating in this study. Patients participated in another clinical study at the same time, unless it is an observational (non intervention) clinical study or is in the follow-up period of an intervention study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruihua Xu
Phone
+86-20-87343468
Email
xurh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Ethics Committee of Sun-Yat-Sen University Cancer Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer

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